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The FDA’s monitoring of in-house emails of five agency whistleblowers that went public with product safety complaints was not supported by agency policy and may have violated the Fourth Amendment and the Whistleblower Protection Act, House Republicans and an HHS watchdog charged Wednesday. Read More
The FDA is proposing that physicians be allowed to perform fecal matter transplants (FMT) in limited circumstances without an investigational new drug (IND) application, provided the physician or their patient knows the donor. Read More
FDA advisors Wednesday urged the agency to rescind the OTC bronchodilator monograph for epinephrine and racepinephrine products delivered via a hand-held rubber bulb nebulizer, saying the combination products present safety concerns that only an NDA can address. Read More
Following recommendations from the FDA, the Drug Enforcement Administration (DEA) is proposing to establish tighter controls on hydrocodone combination drug products such as Vicodin. Read More
The FDA has upgraded the status of Hospira’s troubled Rocky Mount, N.C., manufacturing plant to allow it to begin using the facility to manufacture new products. Read More
Generic drug giants Teva and Mylan are just some of the 13 companies tapped by the FDA to participate in its Secure Supply Chain Pilot Program, an initiative five years in the making that will grant the companies’ products expedited treatment when they enter the U.S. Read More
When drugmakers change analytical validation methods during a drug’s lifecycle, the FDA says they should archive product samples to permit comparative studies of the old and new validation methods. Read More
When submitting information to the FDA in electronic format, sponsors should not confuse the “receipt date” with the “submission date” when filing documents reflecting regulatory milestones such as INDs, NDAs, ANDAs, BLAs and master files, according to finalized agency guidance. Read More
The FDA is examining how drug manufacturers exchange transaction data with their business partners to see if data-gathering methods already in use could satisfy new federal track-and-trace requirements. Read More