We review the in-depth coverage from FDLI’s December conference provided by Govzilla’s Senior GMP Expert Jerry Chapman.
Human Cell and Tissue Therapy Enforcement Actions Target Unapproved New Products Making Unsubstantiated Claims
While some companies are submitting applications to CBER seeking agency approval for marketing HCT/Ps, others are marketing and administering products they claim will treat various diseases and conditions without proof of the claims and without agency approval.
On Friday, March 13, 2020 Covington & Burling hosted a Briefing Call titled “COVID-19: Evolving Considerations for the Life Sciences Industry” spearheaded by the firm’s Food, Drug and Device industry practice. The discussion was wide-ranging and made some important points. We cover these here.
At the FDLI conference held in Washingon, DC in December 2019, CDER Office of Compliance (OC) Director Donald Ashley reviewed FDA’s enforcement firsts from FY 2019.
On Wednesday, March 11, 2020, the World Health Organization declared the spread of the respiratory illnesses caused by the novel coronavirus a pandemic. Here’s how it’s impacting some pharma and device firms.
FDA is expanding its New Inspection Protocol Project (NIPP) inspection methodology, initially piloted exclusively for sterile drug manufacturing facilities, to include other dosage forms, beginning this month.