Barbara Jones-Binns on Food and Drug Administration (FDA)

Food & Beverage Digest – November 2022: Home of Minty Fresh Class Actions

In the November edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries, kombucha creates a buzz, some purported smoked cheese...more

12/1/2022 / Beverage Manufacturers , Class Action , False Advertising , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Marketing , Nutrition Facts Labels , Product Labels

Food and Drug Amendments of 2022 (PDUFA VII)

Our FDA and Health Care Policy teams discuss how sponsors and manufacturers can prepare for legislative and regulatory changes that could come from the final Food and Drug Amendments (PDUFA VII) and what companies can do...more

6/15/2022 / Food and Drug Administration (FDA) , Inspections , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Public Policy , User Fees

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

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

2/1/2022 / Biden Administration , Centers for Disease Control and Prevention (CDC) , Coronavirus/COVID-19 , Cybersecurity , Department of Health and Human Services (HHS) , Executive Orders , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies , Pharmaceutical Industry , Prescription Drugs , Public Health Emergency , Supply Chain , Vaccinations

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

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

1/18/2022 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies , Pharmaceutical Industry , Supply Chain , Vaccinations

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

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

1/4/2022 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies , Pharmaceutical Industry , Supply Chain , Vaccinations

FTC to Probe Supply Chain Issues of Major Companies – Medical Products Supply Chain Week in Review

In the past two weeks, the Federal Trade Commission (FTC) has ordered major U.S. companies to provide information on their supply chain issues and solutions. The FDA issued an emergency use authorization (EUA) for a...more

12/20/2021 / Emergency Use Authorization (EUA) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Medical Supplies , Office of Foreign Assets Control (OFAC) , Supply Chain , Vaccinations

Pfizer and BioNTech to Request Approval for Vaccine Use in 12-to-15-Year-Olds – Medical Products Supply Chain Week in Review

In the past week, Pfizer and BioNTech announced they will request full approval from the FDA for the use of their COVID-19 vaccine in adolescents 12–15 years of age. They also plan to seek authorization of the booster dose in...more

12/6/2021 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medical Devices , Medical Supplies , Pharmaceutical Industry , Popular , Supply Chain , Vaccinations

Barbara Jones-Binns

Alston & Bird

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