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The FDA is scrapping the risk evaluation and mitigation strategy (REMS) for Gilead’s blockbuster HIV drug Truvada and its generics — so manufacturers will no longer have to include educational materials on the drug’s use. Read More
Teva won’t use speakers’ bureaus and won’t provide direct or indirect financial support for branded or unbranded information promoting opioids, the AG said. Read More
“These products have not been demonstrated to be safe or effective for any use and may keep some patients from seeking appropriate, FDA-approved therapies,” the agency said. Read More
An advisory panel said Quizartinib’s application was missing data needed to make a case for treating adults with relapsed or refractory acute myeloid leukemia. Read More
The FDA should limit or at least spell out the different kinds of covariates allowed in randomized trials, a pair of drug industry giants told the agency. Read More
The FDA released draft guidance on Monday on the content and formatting of Instructions for Use (IFU) for prescription drugs, biologics, and drug- or biologic-device combinations. Read More
The FDA flagged the importance of abuse and dependence labeling for prescription drugs and biologics in a new draft guidance issued Monday — calling them key factors in the agency’s drug reviews. Read More
Glenmark Pharmaceuticals said it is “confident” that it can get its investigational allergy spray Ryaltris back on track after the FDA pulled the brakes on its application in the form of a complete response letter. Read More
The FDA released final guidance for sponsors of drugs to treat or prevent serious flare-ups of skin disorders known collectively as epidermolysis bullosa (EB). Read More