Ad Law Tool Kit Show – Episode 1 – Product Safety and Recalls
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
In recent months, the Food and Drug Administration (FDA) announced several recalls related to natural supplements that were found to contain tadalafil and its analogs, the active ingredients in Viagra and Cialis. In its...more
Earlier this month, the U.S. Food and Drug Administration (“FDA”) completed guidance to help companies remove violative products from the market in a swift and effective manner. The guidance describes the precautionary steps...more
The US Food and Drug Administration (FDA) published its Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff (final guidance) on March 4, 2022. The final guidance describes how...more
One by one, at devastating speed, communities across the globe are facing the effects of Covid-19. With more than 115,000 reported cases to date, we are no longer awaiting a new reality; we have met it head on....more
FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...more
Years of adverse-event reports documenting problems associated with compromised food, dangerous drugs and harmful cosmetics are now available to the public. The information can be obtained, free of charge, via a downloadable...more