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The FDA’s proposed new labeling requirements for generics pose such a challenge to industry that GPhA has asked the FDA for an additional two months to comment on the proposed rule. Read More
The Drug Enforcement Administration has placed Eisai's seizure medication Fycompa into schedule III of the Controlled Substances Act, clearing the final regulatory hurdle on the drug's pathway to market. Read More
The FDA’s proposed new labeling requirements for generics pose such a challenge to industry that GPhA has asked the FDA for an additional two months to comment on the proposed rule. Read More
Baxter has issued another recall, this time for a single lot of the nitroglycerin 5 percent dextrose injection, a drug used for pre- and post-operative hypertension, congestive heart failure at the onset of heart attack and chest pain. Read More
A North Carolina pharmacy is recalling all of its sterile compounded drugs distributed within the Tar Heel State and ceasing production of sterile products altogether after an FDA site inspection. Read More
Tamper-evident packaging and registered product trademarks are two features Johnson & Johnson (J&J) employs to minimize a product’s risk of being counterfeited or diverted. Read More
Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. Read More
The FDA plans to launch a study examining how consumers view risk information in direct-to-consumer (DTC) prescription drug advertisements, the latest study delving into how drugmakers craft ads. Read More
The FDA Tuesday hit Wockhardt with a second “import alert,” banning drug products from its Chikalthana plant in western India — the latest in a spate of regulatory actions taken against the struggling drugmaker. Read More
Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. Read More
Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Nov. 25 it is relaxing those restrictions in line with its advisers’ recommendations. Read More
The FDA is seeking input on the effectiveness of risk evaluation and mitigation strategy (REMS) programs as it weighs whether new methods of communicating drug risks in REMS are needed. Read More