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Alston & Bird

Health Care Week in Review: Senate Finance Committee Releases Plan to Address Workforce Shortages, Court Sides with Manufacturers...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Foley & Lardner LLP

Senate HELP Committee’s PREVENT Pandemics Act Draft Released: What to Know

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Following nearly a year of committee hearings, research, policy briefs, and discussion with agency experts, the Senate Health, Education, Labor, and Pensions (HELP) Committee Chairwoman Patty Murray (D-WA) and Ranking Member...more

Alston & Bird

FDA Extends Pause on Non-mission-critical Domestic Surveillance inspections to February 4 – Medical Products Supply Chain Week in...

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In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more

Bradley Arant Boult Cummings LLP

The U.S. Trademark Office Says Δ8-THC Is Illegal -- Usually

The decriminalization of cannabis in some states, and its partial decriminalization at the federal level, has created an explosive market for cannabis itself and the myriad chemicals that compose the plant. The 2018 Farm Bill...more

Alston & Bird

Medical Products Supply Chain Week in Review – August 2021 #4

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Last week, Roche announced a shortage of its drug Actmera/RoActmera, which is used to treat COVID-19. The company, however, does have a mitigation strategy that it plans to implement to lessen the impact. The White House...more

Alston & Bird

Medical Products Supply Chain Week in Review – August 2021 #3

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Last week, the FDA amended the Moderna and Pfizer-BioNTech emergency use authorizations (EUAs) to allow an additional dose of the mRNA COVID-19 vaccine for immunocompromised individuals. In addition, the Secretaries of...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – May 2021 #4

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In the past week, President Biden revealed a new plan to share COVID-19 vaccines with other countries, and the CDC allowed vaccination sites to prioritize vaccinations over minimizing waste; both actions reflect the...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – April 2021 #3

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In the past week, the federal government recommended a pause in the use of Johnson & Johnson’s COVID-19 vaccine due to safety concerns. In addition, the FDA issued the long-awaited guidance on remote interactive evaluations...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – February 2021 #4

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In the past week, the Biden Administration further increased COVID-19 vaccine supply, but the severe winter weather caused widespread delays in vaccine shipments and deliveries. In addition, the Administration announced its...more

Husch Blackwell LLP

Employer Vaccine Update: As FDA Reviews Vaccines, Drug Makers Report Limited Supplies

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The FDA could approve two COVID-19 vaccines within a matter of days. However, drug makers have tried to keep expectations in check about how much vaccine they can deliver immediately and over the next few months as they...more

Husch Blackwell LLP

Updated: Top Employer COVID Vaccine Questions And Answers

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Announcements by both Pfizer and Moderna that their trial COVID-19 vaccines appear to be over 90% effective have led to a surge of interest by everyone, employers included, about exactly when and how a vaccine will save us...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. ...more

ArentFox Schiff

FDA Issues Guidance On What To Do if Employees Test Positive for COVID-19

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The FDA has just issued a Guidance on what it considers to be appropriate Current Good Manufacturing Practices (CGMPs) for Responding to COVID-19 infections in employees in drug and biological manufacturing facilities. ...more

Sheppard Mullin Richter & Hampton LLP

FDA Postpones Ex-US Facility Inspections

U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak. Manufacturers, including contract...more

Akin Gump Strauss Hauer & Feld LLP

A Client’s Guide to FDA Recalls

Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more

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