Washington Drug Letter

While an impending update to the U.S. Pharmacopeia’s (USP) reference standard for heparin sodium will sharpen the drug’s monograph, there is no substitute for solid supplier quality control to prevent contaminants in heparin and other active pharmaceutical ingredients (API), FDA officials say.

Patent settlements that involve a branded company’s commitment to not launch an authorized generic (AG) in competition with a generic company (no-AG agreements) are “without a doubt” anticompetitive pay-for-delay deals even though no cash payments are involved, the FTC says in an amicus brief.

TAMPA, Fla. — The FDA gave drugmakers some key advice for qualifying and auditing contract manufacturers: Start by requesting the same documents the agency wants to see when it begins an audit.

Companies blazing a path in the biosimilars arena likely have a long wait before their products can achieve an interchangeability designation, as the FDA admits to slow progress on that standard.

Drugmakers worry that the FDA doesn’t plan to conduct an honest review of its new drug review program in an upcoming audit.

Drugmakers should use an updated instrument for the prospective assessment of suicidal thoughts and behaviors during clinical trials and follow new FDA advice on which trials and patients need such assessments, according to a new draft guidance.

The FDA has approved Genentech’s Lucentis for an additional indication in diabetic macular edema (DME), making it the first and only agency-approved treatment for the condition.

Drugmakers submitting electronic common technical document (eCTD) marketing applications to both the FDA and European Medicines Agency (EMA) can basically clone their submissions but the format must be reworked to meet the needs of each agency, an eCTD expert advises.

Watson Pharmaceuticals is suing the FDA after it failed to grant the company shared exclusivity on a generic of Type 2 diabetes drug Actos.

The Generic Pharmaceutical Association’s (GPhA) plan to help the FDA deal with drug shortages should launch in the coming weeks, after the FTC found it will not be anticompetitive as sensitive information will be protected.