Life Sciences

Federal Vaccine Mandates – Where Things Stand

Litigation, Government Relations, Health Care, Healthcare, Life Sciences, Public Policy / Elisa Bayoumi

Updated on December 7, 2021 All federal vaccine mandates stayed pending Court action On September 9, 2021, President Biden issued Executive Order 14042: Ensuring Adequate COVID Safety Protocols for Federal Contractors which mandated that employees of federal contractors be fully vaccinated for COVID-19, following recommendations of the Safer Federal Workforce Task Force. In early November 2021, […]

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6th Circuit Selected in Lottery to Hear Lawsuits against OSHA ETS Vaccine and Testing Mandate

Agriculture & Agribusiness, CPSC, EPA, FDA, Government Relations, Health Care, Healthcare, Life Sciences, Public Policy, USDA, USDA FSIS / Kyla S. Kaplan

On November 16, 2021, the Judicial Panel on Multidistrict Litigation, through a lottery system, drew the 6th Circuit as the U.S. Court of Appeals that will hear the consolidated lawsuits against the Occupational Health and Safety Administration (OSHA) Emergency Temporary Standard (ETS) published in the Federal Register on November 5, 2021. The OSHA ETS, which

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FDA Notice of Proposed Rulemaking: Proposed Repeal of HHS Rules on Guidance, Enforcement, and Adjudication Procedures

FDA, Health Care, Healthcare, Life Sciences / Kyla S. Kaplan

On October 20, the United States Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking that would, in relevant part, repeal a Trump Administration rule on, “Department of Health and Human Services Good Guidance Practices,” (GGP Rule) (Dec 7, 2020). The GGP Rule required: Each guidance document issued by HHS

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FDA Announces a DSCSA Public Meeting and Requests Comments

FDA, Health Care, Healthcare, Life Sciences / Tish Eggleston Pahl and Kyla S. Kaplan

The United States Food and Drug Administration (FDA) announced that it will be virtually hosting a public meeting on November 16, 2021, on Drug Supply Chain Security Act (DSCSA) implementation. The purpose of this meeting is to allow interested stakeholders the opportunity to provide input to the FDA on the enhanced drug distribution security provisions

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Long-Awaited DSCSA Guidances Published

FDA, Healthcare, Life Sciences / Tish Eggleston Pahl

On June 3, the Food and Drug Administration (FDA) released four guidances implementing the Drug Supply Chain Security Act (DSCSA). Final Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (Suspect Product Final Guidance) Final Guidance for Industry: Product Identifiers under the Drug Supply Chain Security Act – Questions

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FDA Reverses Trump Administration’s Unapproved Drugs Policy

FDA, Healthcare, Life Sciences / Reed Diskey

On May 26, the Food and Drug Administration (FDA) reversed a Trump Administration policy that revoked the agency’s longstanding Unapproved Drugs Initiative (UDI). On November 15, 2020, then HHS Secretary Alex Azar issued a notice and a request for information entitled “Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for Information Regarding

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FDA Releases Report on Inspections

FDA, Life Sciences / Reed Diskey

On May 5, the Food and Drug Administration (FDA) released a report entitled “Resiliency Roadmap for FDA Inspectional Oversight” discussing its efforts to conduct inspections of food and medical product establishments during COVID-19 and its plan to ensure a more consistent state of operations moving forward. In March 2020, FDA postponed routine domestic and foreign

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FDA Reverses a Trump Administration Drug Review Transparency Policy

FDA, Healthcare, Life Sciences / Reed Diskey

On April 30, the Food and Drug Administration (FDA) reversed a Policy issued by the Department of Health and Human Services (HHS) near the end of the Trump Administration that was purportedly intended to increase drug review timeline transparency. The Policy was announced in the Federal Register on January 15 and would have required FDA

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Janet Woodcock is Named Acting FDA Commissioner, As Stephen Hahn Steps Down

Healthcare, Life Sciences / Michael J. O'Flaherty

In typical fashion, as the new administration took over, i.e., as President Biden was sworn in on Wednesday, Dr. Stephen M. Hahn resigned as FDA Commissioner. His resignation was part of the routine departure of political appointees seen when a new President takes office. Dr. Janet Woodcock has become Acting Commissioner on an interim basis,

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Federal Vaccine Mandates – Where Things Stand

6th Circuit Selected in Lottery to Hear Lawsuits against OSHA ETS Vaccine and Testing Mandate

FDA Notice of Proposed Rulemaking: Proposed Repeal of HHS Rules on Guidance, Enforcement, and Adjudication Procedures

FDA Announces a DSCSA Public Meeting and Requests Comments

Long-Awaited DSCSA Guidances Published

FDA Reverses Trump Administration’s Unapproved Drugs Policy

FDA Releases Report on Inspections

FDA Reverses a Trump Administration Drug Review Transparency Policy

Janet Woodcock is Named Acting FDA Commissioner, As Stephen Hahn Steps Down

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