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The FDA will allow over-the-counter marketing of certain sunscreen products without an approved application provided they avoid certain labeling claims and otherwise comply with all OTC requirements, the agency said in a final guidance. Read More
FDA Commissioner Scott Gottlieb discussed the FDA’s plans to roll out more guidances on cell and gene therapies this year in a Tuesday speech to the Alliance for Regenerative Medicine. Read More
The House of Representatives on Tuesday passed “right to try” legislation in a 250-169 vote despite warnings from House Democrats it would chip away at FDA authority. Read More
The FDA issued draft recommendations for designing and running a maximal usage trial (MUsT) for topical active ingredients that are being considered in an over-the-counter monograph. Read More
The complaint says Novartis agreed not to compete in the generic Exforge market from September 30, 2014 to March 30, 2015, leaving the generics market to Par. Read More
New guidance from the FDA on bioanalytical method validation revises a 2013 document with expanded principles and new appendices on documentation and acceptance criteria. Read More
Clinical trials for acne drugs should limit efficacy assessments to patients’ faces and assess results based on a drug’s effect on the number of lesions and the lesions’ severity, the FDA recommended in a final guidance. Read More
Novartis and Par Pharmaceutical were hit with a pay-for-delay lawsuit filed by Puerto Rican drug manufacturer Drogueria Betances alleging the two companies engaged in years of anticompetitive conduct that delayed generic competition for the hypertension drug, Exforge. Read More
The FDA issued final guidance on electronic submissions of drug master files, giving sponsors of Type III DMFs for packaging materials an extra year before submission requirements kick in. Read More
The FDA announced a new pilot program in which drug sponsors can meet with agency officials to discuss strategies for model-informed drug development (MIDD) to make their clinical trials more efficient and increase the chances of regulatory approval. Read More