Life Sciences Legal Update » Food and Drug Administration (FDA)

The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products. The guidance finalizes an April 2019 draft that advised how...

https://www.lifescienceslegalupdate.com/2022/04/articles/product-liability/product-recalls/fda-finalizes-guidance-on-voluntary-recalls-issues-recommendations-for-industry/

Reed Smith partner Kevin Madagan and associate Julia Lake will return for a second year to help lead a four-hour “Ad Promo Primer” at the Drug Information Association (DIA)’s “Advertising...

https://www.lifescienceslegalupdate.com/2020/05/articles/industry-events/reed-smiths-kevin-madagan-and-julia-lake-to-present-an-advertising-and-promotion-primer-at-dias-regulatory-affairs-conference/

On January 30, 2020, the World Health Organization (WHO) declared novel coronavirus (also known as “2019-nCoV” and “SARS-CoV-2”) a Public Health Emergency of International Concern, and th...

https://www.lifescienceslegalupdate.com/2020/02/articles/regulatory-developments/united-states-federal-and-state-rules-and-regulations-during-public-health-emergencies-navigating-novel-coronavirus/

On January 28, 2020, the Food and Drug Administration (FDA) announced that the Office of Prescription Drug Promotion (OPDP) will conduct two studies to examine how payment disclosure statements a...

https://www.lifescienceslegalupdate.com/2020/02/articles/regulatory-developments/fda-announces-information-collection-on-endorser-status-and-explicitness-of-payment-in-direct-to-consumer-promotion/

On Thursday, January 23, 2020 at 12:00 PM ET, Reed Smith will be hosting “Digital Health 101”, a CLE webinar covering: Federal and state health care regulatory and reimbursement issues, inclu...

https://www.lifescienceslegalupdate.com/2020/01/articles/industry-events/please-join-us-for-an-upcoming-cle-webinar-digital-health-101/

On December 23, 2019, the U.S. Food and Drug Administration (FDA) published in the Federal Register a set of proposed rules covering the requirements and procedures for importing under Section 80...

https://www.lifescienceslegalupdate.com/2020/01/articles/regulatory-developments/fdas-section-804-prescription-drug-importation-program-and-801d1b-guidance/

As 2019 comes to an end, the United States Food & Drug Administration’s (“FDA” or the “Agency”) Center for Veterinary Medicine has published a new draft Guidance for Industry #256, “C...

https://www.lifescienceslegalupdate.com/2019/11/articles/regulatory-developments/fda-publishes-new-draft-guidance-on-animal-drug-compounding/

Please join us for the next edition of Reed Smith’s FDA webinar series, “CBD: What now?”, on Wednesday, October 30, 2019 at 12:00 PM ET. Cori Goldberg, Marc Hauser, and Adam Brownrout will ...

https://www.lifescienceslegalupdate.com/2019/10/articles/industry-events/join-us-for-a-cle-webinar-on-the-current-federal-and-state-regulations-for-cannabidiol-cbd/

As part of our FDA series, Reed Smith will be hosting the upcoming webinar, “FDA inspections of health care facilities: How to keep calm and carry on when FDA walks through your door” on Thur...

https://www.lifescienceslegalupdate.com/2019/10/articles/industry-events/join-us-for-a-webinar-covering-fda-inspections-of-health-care-facilities-how-to-keep-calm-and-carry-on-when-fda-walks-through-your-door/

On October 2, 2019, the United States Food & Drug Administration (FDA) announced that it awarded a cooperative agreement grant to the National Association of Boards of Pharmacy (NABP) to establis...

https://www.lifescienceslegalupdate.com/2019/10/articles/regulatory-developments/fda-partners-with-the-national-association-of-boards-of-pharmacy-to-create-an-information-sharing-system-for-drug-compounding-activities/