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In the wake of record-breaking numbers of drug shortages, particularly generic injectables, the European Federation of Pharmaceutical Industries and Associations (EFPIA) is advising drugmakers to establish a drug shortage task force. Read More
Drugmakers will soon have to seek Federal Trade Commission antitrust review for all proposed licensing agreements for “exclusive” patent rights. Read More
The European Medicines Agency (EMA) has provided generic drugmakers its first roadmap to meeting standardized EU bioequivalence requirements. Read More
A California judge has ruled that Sandoz must file an application with the FDA for approval of a biosimilar referencing Amgen’s biologic arthritis drug Enbrel before it can challenge the brand drug’s patents. Read More
The FDA plans to shift its focus during facility inspections away from examining documentation, such as standard operating procedures, and place more emphasis on a facility’s operational metrics. Read More
For the first time brand and generic drugmakers are required to notify the EMA and individual country regulators when they withdraw a drug from the market anywhere in the EU, and the reasons why, to comply with the EU’s newly amended pharmacovigilance law. Read More
The Supreme Court Nov. 13 dealt generic giant Teva a major blow as it denied the company’s request to stay a lower court’s ruling that will allow generic versions of the drugmaker’s blockbuster brand drug Copaxone to hit pharmacy shelves in May. Read More
Drugmakers have 13 months to revamp how they track drugs after the Senate voted Nov. 18 to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
The FDA is proposing to give generic drugmakers the power to revise product labeling in response to safety issues prior to agency approval — a power that brand drugmakers already have. Read More
Just months after Sanofi began preparing regulatory filings for its blood cancer drug candidate fedratinib, the company said Monday newly raised safety concerns have forced it to scrap its plans. Read More
A drug’s active ingredient name does not need to appear every time its brand name is repeated in an advertisement, the FDA says, clarifying the most common advertising issue that drugmakers question the agency about. Read More
Congress rejected the FDA’s call for mandatory oversight of compounding pharmacies, passing legislation Monday that instead allows compounders to volunteer for agency oversight. Read More