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Drugmakers in the EU must create a program to assess the effectiveness of their risk minimization efforts for each marketed drug, EU regulators say. Read More
The FDA and the European Medicines Agency (EMA) have completed their analysis of study data on incretin-based type 2 diabetes drugs and conclude they do not increase the risk for pancreatitis or pancreatic cancer. Read More
Endo Pharmaceuticals has entered into a five-year corporate integrity agreement with HHS to resolve marketing violations surrounding the Lidoderm patch, a popular painkiller. Read More
The FDA says sponsors of antiretroviral drugs should submit clinical trial data sets that include patient data, endpoint data, genotypic data and phenotypic data when reporting data on HIV-1 resistance to the agency in support of an HIV drug. Read More
Drugmakers seeking marketing authorization in Australia will soon be able to make complete submissions in electronic format, allowing for cost savings and potentially swifter reviews. Read More
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
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