2024 Fda calendar for drug approval - Key US FDA PDUFA Dates Pure Pharma News. Fda Drug Approval Calendar. Cder drug and biologic approvals for calendar year 2021. Cder drug and biologic ...

 
Listen to a soundcast of the November 8th 2022 FDA approval of Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for non-small cell lung cancer. Fda calendar for drug approval

See the Development & Approval Process page for a description of what products are approved as Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510Ks.Oct 26, 2023 · An FDA Calendar typically displays information about the expected timeline for a particular drug approval or PDUFA date. The calendar will also provide key information such as what type of approval is being sought (e.g. full approval, tentative approval, accelerated approval), and any publicly available information about the expected decision ... The Committee will receive updates on the accelerated approval program in oncology and two new drug applications (NDAs) approved under 21 CFR 314.500 (subpart H, accelerated approval regulations ...45 novel drugs. In calendar year 2015, FDA’s Center for Drug Evaluation and Research ... CDER used a number of regulatory methods to expedite the development and approval of novel drugs in 2015.October 2023. October 27, 2023 - FDA Roundup: October 27, 2023. October 26, 2023 - FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants. October 24, 2023 - FDA ...(b) Within 30 calendar days of the withdrawal of an approved drug from sale ... FDA's tentative approval of a drug product is based on information available to ...CFR - Code of Federal Regulations Title 21. The information on this page is current as of Oct 17, 2023. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 314.80 Postmarketing reporting of adverse drug experiences. (a) Definitions.FDA’s Labeling Resources for Human Prescription Drugs. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products. This Week's Drug Approvals. CDER highlights key ... Comprehensive suite of tools for trading and investing in biotech stocks. FDA Calendar, PDUFA Date Calendar, Biotech Company Screener and Database and much more.FDA Roundup: July 21, 2023. Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA Center for Tobacco Products (CTP ...Agenda. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss new drug application 213931, for tenapanor ...On earlier notification by FDA indicating the clinical investigations in the IND may begin (21 CFR 312.40 (b)) The period between when the FDA receives the IND and when it goes into effect is often referred to as the “30-day hold.”. It’s at the end of that period, unless one of the above criteria is met, when an IND automatically goes ...The FDA does not approve cosmetics. Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations. Cosmetic products and ...Counting the number of global approvals, around 93% of approved antibody therapies were first approved by only four major drug regulatory agencies, which are the FDA in the US, the European Medicines Agency (EMA) in Europe, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and the National Medical Products …In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must ...The PDUFA calendar plays a vital role in expediting FDA drug reviews and shaping the pharmaceutical landscape. By establishing timelines and goals, it provides predictability for pharmaceutical companies and offers hope for patients awaiting innovative treatments. Ultimately, the PDUFA process aims to streamline drug approvals, enhance patient ...The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed ...Center: CDER Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing ...Drug approval process in US, Europe and India and its regulatory requirements: A Review. Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory ...... FDA Performance Tracker Approvals Drug Approval Standards. A Standard ... Source: Shutterstock The bus is empty; FDA's user fee calendar is only slightly more ...Graphic of a calendar with the date January 10, 2024, and the text ". read ... approved-drugs/fda-approves-nirogacestat-desmoid-tumors… #OCENewsBurst. FDA ...Jun 3, 2022. This statistic shows the time from filing to approval for NDA/BLA filings for new drugs in the U.S., in the period from January 1, 2011, to November 30, 2020, by disease area. It was ...The oral triple-combination therapy was previously approved for the treatment of moderate to severe pain associated with endometriosis in August 2022. A gonadotropin-releasing hormone (GnRH) antagonist therapy, MYFEMBREE represents not only a potential variable drug option for gynecologic condition-associated pain—but added diversity to ...The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed ...Agenda. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss new drug application 213931, for tenapanor ...CY 2021 CDER Drug and Biologic Calendar Year Approvals. As of December 31, 2021. ... Approvals: BLA NUMBER PROPRIETARY NAME PROPER NAME APPLICANT REVIEW CLASSIFICATION APPROVAL DATE Eli Lilly and Co said on Thursday the U.S. Food and Drug Administration (FDA) had agreed to a quick review of its diabetes drug Mounjaro to treat obesity, months after a study showed it helped .... On Wednesday, Nov. 22, the FDA issued the final guidance “ COVID-19: Developing Drugs and Biological Products for Treatment or Prevention .” The guidance …13 de jul. de 2023 ... The FDA approved 22 new drugs during the first half of 2023, including notable newcomers Inpefa (sotagliflozin) for heart failure, ...The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Act of 2017 (PDUFA VI), authorizes FDA to assess and collect fees for prescription drug ... Background. Previous research focused on the clinical evidence supporting new cancer drugs’ initial US Food and Drug Administration (FDA) approval. However, targeted drugs are increasingly approved for supplementary indications of unknown evidence and benefit. Objectives. To examine the clinical trial evidence supporting new …The Food and Drug Administration has given its full approval of the Pfizer-BioNTech COVID-19 vaccine, calling it a "key achievement for public health." The two-dose vaccine is now fully approved ...NDA and BLA Calendar Year Approvals. New Molecular Entity (NME) Drug and New Biologic Approvals. Priority NDA and BLA Approvals. Efficacy Supplement Approvals. NDA and BLA Approval Times. Fast ...Questions can be addressed to John P. Swann, Ph.D., FDA Historian, FDA History Office, White Oak Building 32, Room 3322, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, john.swann@fda ...Center: Center for Drug Evaluation and Research Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via ...Canalevia ®-CA1 is the first and only treatment for chemotherapy-induced diarrhea (CID) in dogs to receive any type of approval from the FDA. Crofelemer, …For meetings that occurred in 2017-2020, please use this link and for meetings that occurred in 2016 or earlier, please see the FDA Archive. 2023 Public Calendars July/August 2023Level 1 controlled correspondence is correspondence submitted to the Agency, by or on behalf of a generic drug manufacturer or related industry, requesting information on a specific element of ...Prior to approval, new drugs go through many steps, or “phases” during the approval process. They are first tested on animals, then on small groups of humans for preliminary safety information ...A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring. First, the company must conduct laboratory tests and try the drug on animals and then people to make sure it works and is safe.The PDUFA calendar plays a vital role in expediting FDA drug reviews and shaping the pharmaceutical landscape. By establishing timelines and goals, it provides …Questions can be addressed to John P. Swann, Ph.D., FDA Historian, FDA History Office, White Oak Building 32, Room 3322, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, john.swann@fda ... Entrada Therapeutics Says FDA Declines To Lift Clinical Hold On ENTR-601-44 IND Application. Biopharmaceutical company Entrada Therapeutics, Inc. (TRDA) announced Wednesday the completion of dosing for the first and second cohorts of its Phase 1 clinical trial, ENTR-601-44-101. Entrada plans to announce data from ENTR-601-44-101 in the second ...Agenda. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss new drug application 213931, for tenapanor ...PDUFA date: November 17, 2023. The FDA is reviewing the resubmitted New Drug Application (NDA) for vonoprazan, an oral small molecule potassium-competitive acid blocker, for the treatment of ...Results: The total number of novel drugs approved from CY 2012 to 2018 was 279 (average 40 novel drugs/ year). Impact of novel drug approvals: 50% were first in class and 43% were for rare diseases. Overall expedited development and review methods were used in 63% of the novel drug approvals. Access of novel drug approvals: 84% were first-cycle ...FDA decisions (approvals/complete response letter/delay) According to special statuses for treatment options, including orphan drug designation, rare disease designation, accelerated approval ...Amylyx said Friday that Relyvrio will cost about $12,500 for a 28-day supply, or $158,000 a year before insurance. That's below the price of an older ALS drug, edaravone, which costs around ...Eli Lilly and Co said on Thursday the U.S. Food and Drug Administration (FDA) had agreed to a quick review of its diabetes drug Mounjaro to treat obesity, months after a study showed it helped ...Investing in Biotech and Pharma. RTT tracks and monitors hundreds of companies and potential market-moving events. These include pending new drug approvals, new FDA submissions, pending mid/early-stage clinical trial results, late-stage phase 3 clinical trial results, FDA advisory panel meetings and much more. chevron_right.PDUFA date: November 17, 2023. The FDA is reviewing the resubmitted New Drug Application (NDA) for vonoprazan, an oral small molecule potassium-competitive acid blocker, for the treatment of ...CDER New Molecular Entity (NME) and Original Biologic Approvals Calendar Year 2022. CDER New Molecular Entity (NME) and Original Biologic Approvals Calendar Year 2021. CDER New Molecular Entity ...CDER New Molecular Entity (NME) and Original Biologic Approvals Calendar Year 2022. CDER New Molecular Entity (NME) and Original Biologic Approvals Calendar Year 2021. CDER New Molecular Entity ...The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses ...Cibinqo. abrocitinib. 1/14/2022. To treat refractory, moderate-to-severe atopic dermatitis. …A new treatment has been approved by the FDA for treatment of ovarian cancer. The treatment is made by Clovis Oncology....CLVS Clovis Oncology ( (CLVS) ) won approval today for its new ovarian cancer drug known as Rubraca. According to the ...Apr 24, 2023 · PDUFA VII Reauthorization Proposed Enhancements Public Meeting - September 28, 2021. The Food and Drug Administration (FDA or Agency) is announcing a virtual public meeting to discuss the proposed ... Amylyx said Friday that Relyvrio will cost about $12,500 for a 28-day supply, or $158,000 a year before insurance. That's below the price of an older ALS drug, edaravone, which costs around ...The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Act of 2017 (PDUFA VI), authorizes FDA to assess and collect fees for prescription drug ...The FDA kept up the pace in the third quarter, approving 14 new drugs (Table 1). This total slightly beats the Q1 and Q2 tallies (at 13 each), meaning 2023 year to date …Feb 17, 2023 · See the Development & Approval Process page for a description of what products are approved as Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510Ks. Historical Medical Device Calendar. Historical Medical Device Calendar lists historical catalysts from clinical trial results and FDA clearance decisions. Comprehensive suite of tools for trading and investing in biotech stocks. FDA Calendar, PDUFA Date Calendar, Biotech Company Screener and Database and much more.Today, the U.S. Food and Drug Administration granted approval for Amondys 45 (casimersen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation ...Mar 19, 2023 · The PDUFA calendar plays a vital role in expediting FDA drug reviews and shaping the pharmaceutical landscape. By establishing timelines and goals, it provides predictability for pharmaceutical companies and offers hope for patients awaiting innovative treatments. Ultimately, the PDUFA process aims to streamline drug approvals, enhance patient ... 29 de set. de 2023 ... To help our readers keep track of the cancer therapies approved by the U.S. Food and Drug Administration (FDA), understand their impact for ...For example, OTC drug products previously available only by prescription are first approved through the NDA process and their "switch" to OTC status is approved via the NDA process. OTC ...Mar 2, 2023 · CDER Priority Drug and Biologic Approvals in Calendar Year 2015; Content current as of: 03/02/2023. ... Follow FDA on LinkedIn View FDA videos on YouTube Subscribe to FDA RSS feeds. The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses ... A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring. First, the company must conduct laboratory tests and try the drug on animals and then people to make sure it works and is safe.On December 15, 2022 the FDA listed Mounjaro as one of almost 200 drugs in a supply shortage, joining Wegovy, Ozempic (semaglutide) and Trulicity (dulaglutide), Eli Lilly’s other diabetes drug ...For non-application drugs, such as over-the-counter monograph products, the manufacturer must also conduct stability testing to establish an expiration date and storage conditions to meet FDA’s ...... approval or post approval process utilizes an FDA Ad Comm meeting. FDA Ad ... The Open Public Hearing at FDA Advisory Committee Meetings U. S. Food and Drug ...The FDCA and FDA regulations require that all prescription drug advertisements discussing the effectiveness or indications of the drug must include a brief summary of side effects, contraindications, and …The FDA accepted a New Drug Application (NDA) for the dual SGLT-1 and 2 inhibitor last July, on the backing of the randomized, double-blind SOLOIST-WHF trial data showing sotagliflozin plus standard care was associated with a significant reduction in major adverse cardiovascular events (MACE) among treated patients with type 2 diabetes who had ...1998-2014 reports are in the FDA Archive Efficacy Supplement Reports. New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2022FDA Calendar, PDUFA Date Calendar, Biotech Company Screener and Database and much more Comprehensive suite of tools for trading and investing in biotech stocks. Profit on the stock market by investing in biotech stocks Cancer approvals still dominate, accounting for 15 (30%) of the new approvals (Fig. 2). The 5-year average for cancer approvals is 28%. Neurology drugs secured the second most approvals, for the ...Cancer approvals still dominate, accounting for 15 (30%) of the new approvals (Fig. 2). The 5-year average for cancer approvals is 28%. Neurology drugs secured the second most approvals, for the ...11/17/2017. This draft guidance, and other guidance documents that are part of the comprehensive policy framework for the regulation of regenerative medicine products, can be accessed here. ocod ...Fda calendar for drug approval

In the month of January, the FDA approved only two novel drugs – Leqembi and Brenzavvy - compared to 4 in the same month last year. Leqembi, for the treatment of Alzheimer's disease, was granted accelerated approval on January 6. Brenzavvy, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes .... Fda calendar for drug approval

fda calendar for drug approval

16 de mai. de 2023 ... The FDA approved 43 novel new drugs for 44 indications (one drug was ... approvals by the U.S. as tabulated by calendar year in the FDA website.Cancer approvals still dominate, accounting for 15 (30%) of the new approvals (Fig. 2). The 5-year average for cancer approvals is 28%. Neurology drugs secured the second most approvals, for the ...The Food and Drug Administration has given its full approval of the Pfizer-BioNTech COVID-19 vaccine, calling it a "key achievement for public health." The two-dose vaccine is now fully approved ...FDA Roundup: July 21, 2023. Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA Center for Tobacco Products (CTP ...FDA Approval of HIV Medicines HIVINFO. Fda Drug Approval Calendar. Web novel drug approvals for 2022 advancing health through innovation: Cder drug and ...The CDER Breakthrough Therapy (BT) Approvals reports contain a list of approvals for breakthrough therapy designated drugs. New reports will be published quarterly for the current calendar year (CY).See the Development & Approval Process page for a description of what products are approved as Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510Ks.On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022, which includes the reauthorization of the Prescription Drug User Fee Act (PDUFA VII) from fiscal ...Oct 19, 2023 · 7/16/2021. To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense. Drug Trials Snapshot. 29. Kerendia. finerenone. 7/9/2021. To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes. Drug Trials Snapshot. This article examines the status of confirmatory studies of drugs approved under the US Food and Drug Administration’s (FDA’s) accelerated approval program …Drugs@FDA includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other information are available for drug products ...Forty-one percent of readers expect FDA full approval on Oct. 29; 36% expect an FDA complete response letter; and another 23% say FDA will push the approval …Editor’s Note: If you or someone you know is living with an opioid addiction or another substance use disorder, know that help is available. Narcan, also known as Naloxone, is an FDA-approved medication that’s designed to rapidly reduce the...... schedule of stepped-up dosing and other measures to mitigate these ... The drug received accelerated approval from the US Food and Drug Administration (FDA) ...An FDA Calendar typically displays information about the expected timeline for a particular drug approval or PDUFA date. The calendar will also provide key information such as what type of approval is being sought (e.g. full approval, tentative approval, accelerated approval), and any publicly available information about the expected decision date.Contact. 435 Merchant Walk Square, Suite 300-145; Charlottesville, VA 22902 Biologics License Applications and Supplements. New BLAs (except those for blood banking), and BLA supplements that are expected to significantly enhance the public health (e.g., for new/expanded ...In 2013, an over-the-counter version of Nasonex was FDA-approved and the drug can now be found in local drug stores, writes the FDA on their site. Nasacort Allergy 24HR can be used on children who are 2 years old or older as well as teens a...October 2023. October 27, 2023 - FDA Roundup: October 27, 2023. October 26, 2023 - FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants. October 24, 2023 - FDA ...Canalevia ®-CA1 is the first and only treatment for chemotherapy-induced diarrhea (CID) in dogs to receive any type of approval from the FDA Crofelemer, Jaguar's novel, oral plant-based drug ...Our enhanced FDA calendar integrates PDUFA dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers all companies facing upcoming PDUFA dates. Streamline your research and quickly compare the relative timing of competing catalysts.Oct 20, 2023 · An FDA Calendar typically displays information about the expected timeline for a particular drug approval or PDUFA date. The calendar will also provide key information such as what type of approval is being sought (e.g. full approval, tentative approval, accelerated approval), and any publicly available information about the expected decision date. Listen to the article 5 min. December is often a busy month at the FDA as the agency moves to fit in several drug approvals before the end of the year. In 2021, for example, the agency gave the go-ahead to four novel therapies between Dec. 17 to Dec. 27. So far in 2022, the FDA has approved 30 novel drugs — while short of last year's 50 ...Contact. 435 Merchant Walk Square, Suite 300-145; Charlottesville, VA 22902Entrada Therapeutics Says FDA Declines To Lift Clinical Hold On ENTR-601-44 IND Application. Biopharmaceutical company Entrada Therapeutics, Inc. (TRDA) announced Wednesday the completion of dosing for the first and second cohorts of its Phase 1 clinical trial, ENTR-601-44-101. Entrada plans to announce data from ENTR-601-44-101 in the second ...Though the agency has made strides over the years to expedite review in the face of limited resources, the total time elapsed between FDA's filing of an NDA or receipt of an ANDA to ultimate approval or disapproval of the application often exceeds 180 days. Even so, reporting on drug approvals, such as GAO's March 2020 report, [ 7] focused .... On Wednesday, Nov. 22, the FDA issued the final guidance “ COVID-19: Developing Drugs and Biological Products for Treatment or Prevention .” The guidance …Almost half of all novel medications approved by the U.S. Food and Drug Administration (FDA) are orphan drugs. Below is the list of important regulatory dates for …For example, OTC drug products previously available only by prescription are first approved through the NDA process and their "switch" to OTC status is approved via the NDA process. OTC ...Jul 21, 2023 · FDA Roundup: July 21, 2023. Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA Center for Tobacco Products (CTP ... Agenda. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On April 21, 2022, the committee will discuss the appropriate approach ...For meetings that occurred in 2017-2020, please use this link and for meetings that occurred in 2016 or earlier, please see the FDA Archive. 2021 Public Calendars November/December 2021For the third year in a row, Evaluate Vantage’s mostly hotly tipped drug approval for 2023 when it comes to future sales potential is an Alzheimer’s therapy. For the third year in a row, Evaluate Vantage’s mostly hotly tipped drug approval for 2023 when it comes to future sales potential is an Alzheimer’s therapy.The FDA Accelerated Approval pathway, which has been pivotal in enabling early access to new oncology drugs over the past three decades, has recently come under increased scrutiny. New draft ...In the early part of the 20th century, the U.S. Food and Drug Administration (FDA) was given the responsibility for ensuring both the safety and efficacy of drugs prior to marketing .Amendments to the Federal Food Drug and Cosmetics Act in 1976 expanded the agency's role to oversee safety in the development of medical devices .Whereas new …2 de mar. de 2023 ... Reports · CDER Priority Drug and Biologic Approvals in Calendar Year 2022 · CDER Priority Drug and Biologic Approvals in Calendar Year 2021 · CDER ...Published: November 13, 2023. Prevention and Treatment of Anthrax. Society: Centers for Disease Control and Prevention (CDC) Published: November 14, 2023. …ATHA. Topline results from phase II/III clinical trial of ATH-1017 (LIFT-AD) Mild-to-moderate Alzheimer's. 2024. Albireo Pharma, Inc. ALBO. Topline data from phase III trial of Bylvay (BOLD) Biliary atresia. 1H 2024. Almost half of all novel medications approved by the U.S. Food and Drug Administration (FDA) are orphan drugs. Below is the list of important regulatory dates for …The company said the health regulator gave the new approval to the drug for the treatment of chronic lymphocytic leukemia (CLL), a type of cancer in which the bone …A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that ...16 de mai. de 2023 ... The FDA approved 43 novel new drugs for 44 indications (one drug was ... approvals by the U.S. as tabulated by calendar year in the FDA website.New Drug Application (NDA)-- When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval ...Jun 9, 2023 · This week, the FDA sent to Congress its Report on Drug Shortages for Calendar Year 2022, the tenth annual report, to summarize major actions taken by the agency to prevent or mitigate drug ... 11/17/2017. This draft guidance, and other guidance documents that are part of the comprehensive policy framework for the regulation of regenerative medicine products, can be accessed here. ocod ...The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Act of 2017 (PDUFA VI), authorizes FDA to assess and collect fees for prescription drug ...Prior to approval, new drugs go through many steps, or “phases” during the approval process. They are first tested on animals, then on small groups of humans for preliminary safety information .... What are the chances of a government shutdown 2023