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The FDA has broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. Only Ipca’s anti-malarial API remains exempted and can be imported into the U.S. Read More
FDA Commissioner Scott Gottlieb outlined an action plan to remove barriers to generic competition, saying agency regulations have been “gamed” by brand-name manufacturers to delay generic drug approvals even after patents and exclusivity periods lapse. Read More
China has joined the ICH as its eighth regulatory member, pledging to gradually transform its pharmaceutical regulatory authorities, industry and research institutions to implement the international coalition’s technical standards and guidelines. Read More
The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable technology and the use of outsourcing and contracting. Read More
The FDA will clear its backlog of orphan drug designation requests in the next 90 days, Commissioner Scott Gottlieb told Senate appropriators, and the agency plans to assign a team dedicated to assessing the approximately 200 applications currently pending. Read More