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Vaccinations Manufacturers Pharmaceutical Industry

Butler Snow LLP

Turnabout is Fair Play – “Junk Science” Litigation Aftermath: Requisite Retractions and Dubious Do-Overs

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Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Vaccination Program

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-11 (the “Opinion”), to a pharmaceutical manufacturer (the...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

Alston & Bird

FDA Suspends Non-Mission-Critical Domestic and Foreign Inspections – Medical Products Supply Chain Week in Review

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Just before the New Year holiday, the FDA announced it that was suspending non-mission-critical domestic and foreign inspection activities. The FDA amended the EUA of the Moderna COVID-19 vaccine booster. The Center for Drug...more

Alston & Bird

FDA Authorizes Booster Dose for Adolescents – Medical Products Supply Chain Week in Review

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Over the holidays, the CDC updated its recommendations for post-exposure quarantining and masking. The FDA authorized the Pfizer vaccine booster dose for adolescents 12–15 years of age and for immunocompromised children 5–11...more

Alston & Bird

Medical Products Supply Chain Week in Review – November 2021 #2

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In the past week, the President has selected Dr. Robert Califf to be FDA commissioner. Congress passed the Infrastructure Investment and Jobs Act. New vaccination requirements were issued by OSHA and CMS for certain...more

Alston & Bird

Medical Products Supply Chain Week in Review – November 2021 #1

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In the past week, the FDA granted an EUA for the Pfizer-BioNTech vaccine for use in children 5–11 years of age. The agency also participated in the launch of the Bespoke Gene Therapy Consortium. The Administration held a...more

Alston & Bird

Medical Products Supply Chain Week in Review – October 2021 #1

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Last week, AstraZeneca and Merck filed emergency use authorization (EUA) requests for their COVID-19 drugs. The FDA provided information to the public about a database repository of gene variants and associated conditions....more

Akin Gump Strauss Hauer & Feld LLP

[Podcast] Onshoring Drug Manufacturing and TRIPS Waiver Part II

In this new episode of OnAir: Health Care, Akin Gump health care senior policy advisor Matthew Hittle and consultant Dr. Mario Ramirez welcome Akin Gump public law and policy partner Clete Willems and Centrient...more

Alston & Bird

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

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Last week, six U.S. agencies updated an advisory to urge businesses to conduct human rights due diligence for supply chain links to Xinjiang, China. In addition, the Pfizer/BioNTech COVID-19 vaccine received Priority Review...more

Smart & Biggar

Transition measures released for Interim Order for COVID-19 drugs

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As previously reported... on September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order), which...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – April 2021 #2

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In the past week, President Biden announced a new vaccination progress target, while the Baltimore facility incident affected Johnson & Johnson’s vaccine delivery. In addition, the FDA issued a guidance document regarding...more

Alston & Bird

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

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In the past week, senior FDA officials revealed that the FDA is preparing for more inspections and exploring new inspection technologies. In addition, the Biden Administration announced a loan of AstraZeneca vaccines to...more

Alston & Bird

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

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In the past week, President Biden signed the American Rescue Plan, which provides $10 billion to expand domestic production of medical supplies. The President also announced that all adults in the U.S. will be eligible for...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – March 2021 #2

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In the past week, Johnson & Johnson and Merck agreed to cooperate on production of the Janssen vaccine, and the Biden Administration used the Defense Production Act (DPA) to facilitate the arrangement. In addition, the GAO...more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...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

BakerHostetler

FDA and Pharmacy Weekly Digest - October 2020 #2

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Food - FDA Released Retail Food Employee Health Handbook – The FDA published the Employee Health and Personal Hygiene Handbook to help food employees avoid spreading viruses and bacteria to food....more

Patterson Belknap Webb & Tyler LLP

FDA Releases COVID-19 Vaccine Guidance for Industry

On June 30, 2020 the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research released its first “Guidance for Industry” document for the development and licensure of COVID-19 vaccines. While the...more

The Volkov Law Group

Drug and Medical Device Fraud Risks Increase in Pandemic Era

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The drug and medical device/testing industry is under significant pressure to develop new products to address the COVID-19 pandemic.  The federal government is increasing spending and support of drug and device companies in...more

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