Four pharmaceutical stakeholders submit comments on an FDA draft guidance on writing the Indications and Usage section in product labeling.
Indias Lupin says an FDA inspection at its Tarapur drug manufacturing facility closed with one observation the company considers to be a procedural de...
FDA warns Chinas Longwood Medicine (Beijing) about CGMP violations in its production of an unapproved new drug.
Federal Register notice: FDA makes available a draft guidance entitled Postapproval Changes to Drug Substances.
Federal Register notice: FDA submits to OMB an information collection extension Guidance for Industry: Formal Meetings between the Food and Drug Admin...
Former FDA chief counsel Rebecca Wood rejoins Sidley Austin to co-lead both the firms food, drug and medical device regulatory practice and its FDA gr...
Cook Medical gets an FDA close-out letter resolving a 2014 Warning Letter for processes related to the companys quality system at its manufacturing fa...
FDA releases its latest batch of Warning Letters that include Lernapharm (Loris), Longood Medicine and two letters to Medtronic.