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Drug manufacturers using Shanghai Medical Ltd. as their source of active pharmaceutical ingredients (APIs) may have trouble getting new products approved by the FDA or imported into the U.S. following a warning letter that questioned the training of the firm’s quality staff, the validity of its records and its storage of reference standards.
The FDA cannot accept Minnesota Gov. Tim Pawlenty’s invitation to inspect the operation of its drug reimportation website, according to a high-ranking agency official. “The FDA does not have the legal authority to engage in the sort of test program that Gov. Pawlenty is proposing,” William Hubbard, the FDA’s associate commissioner for policy and planning, told DID yesterday.
The FDA is closing in on the release of a new guidance that will address the scientific challenges in creating generic biologics and provide a foundation for a possible legal and regulatory framework for approving the complex treatments.
The FDA soon will begin disclosing on its website the date it receives the first substantially complete abbreviated new drug application containing a challenge to a patent on a brand drug to help generic drug manufacturers determine if they are eligible for marketing exclusivity.
In an effort to squelch the FDA’s criticism of Minnesota’s Rx drug reimportation website, Gov. Tim Pawlenty has invited the agency to inspect the operation and test the safety and validity of the state’s approach to providing U.S. residents with information on obtaining pharmaceuticals from Canada.
The National Institutes of Health (NIH) recently informed women involved in an estrogen treatment study to stop taking their pills due to an increased risk for stroke associated with the treatment, NIH announced yesterday.
Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and ranking committee Democrat Sen. Max Baucus (D-Mont.) have agreed to approve the nomination of FDA Commissioner Mark McClellan as head of the Centers for Medicare & Medicaid Services.
Pfizer announced yesterday it will discontinue clinical studies into the effectiveness of the impotence drug Viagra as a treatment for female sexual arousal disorder because of inconclusive results that would not support a filing with the FDA.
The brand industry is eyeing a new legal-delay tactic against generic competition that uses the fear of crippling financial damages to prevent generic firms from launching products, according to the head of the FTC.