Regulatory Affairs

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Drugmakers should add microbiology and pharmacogenomics subsections to their prescription drug and biologic product labels when necessary, according to FDA draft guidance released Wednesday. Read More

Two industry groups in India are suing the country’s drug regulatory authority for enacting price controls on scores of branded generic drugs to treat diabetes and cardiovascular disorders. Read More

Generics manufacturer Akorn must sell its rights to a pending ANDA for the tuberculosis drug rifampin before it can complete its $324 million acquisition of VersaPharm, the Federal Trade Commission said. Read More

The FDA will grant marketing exclusivity only to biologics that are fundamentally different from existing products, according to new guidance that explains what manufacturers must do to lock in protection from biosmiliar competition. Read More

Countries in the Caribbean are working to establish a unified registration process for generic drugs, an effort aimed to improve the quality, availability and access to essential therapies. Read More

The U.S. biotechnology industry has endorsed a recent World Health Organization proposal to give biosimilar products a unique name qualifier that distinguishes them from the reference products’ nonproprietary name, a proposal that may run counter to naming protocols in the generic drug industry. Read More

Manufacturers of new drugs, biologics and biosimilars will pay slightly more in user fees this fall for their applications, facilities and products. Read More

The FDA expects to collect $312.2 million in generic drug user fees next fiscal year, with companies paying slightly less for each ANDA filing and facilities that produce active pharmaceutical ingredients and finished generic products paying more. Read More

Generics manufacturers seeking product approvals in the European Union can opt to share the resulting application reviews with regulatory bodies outside the bloc under a pilot program designed to coordinate drug approvals across international borders. Read More

Complaints of particulates found in vials of nine lots of Cubist Pharmaceuticals’ anti-infective drug Cubicin prompted the company to initiate its second recall of the drug in as many days. Read More

Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than stage by stage, which is the current policy. Read More