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After serving as FDA commissioner for six years, Margaret Hamburg has resigned, ending a tenure during which the agency boosted its focus on drugs for unmet needs, strengthened policing of compounding pharmacies and increased drug approvals. Read More
The court ruled that a brand drugmaker’s payment to settle an infringement case that delays generic competition can support a pay-for-delay claim. Read More
Australian regulators are calling for labels on six types of nonsteroidal anti-inflammatory drugs to include strong warnings about cardiovascular and liver risks associated with excessive or prolonged use. Read More
Pfizer’s novel breast cancer drug Ibrance shows reasonable evidence of clinical benefit to warrant marketing it ahead of a Phase III study, the FDA said in granting accelerated approval Tuesday. Read More
Generic drugmakers charge a December draft guidance doesn’t go far enough in enabling them to obtain bioequivalence testing batches for drugs protected by REMS product safety protocols. Read More
The FDA warned an Indian manufacturer to immediately stop ignoring poor test results, the second Indian facility in a week to get a warning letter for data integrity violations. Read More
The FDA is creating a simple, one-step process for physicians to gain access to experimental drugs for patients facing terminal, untreatable conditions. Read More