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The FDA has announced that it will not impose restrictions on “IRB shopping,” a practice in which clinical trial sponsors submit trial research to institutional review boards (IRBs) that they feel are likely to approve the trial. The agency’s statement was published in the Jan. 17 Federal Register.
An advisory committee for the European Medicines Agency (EMEA) has recommended the approval of Sandoz’ human growth hormone Omnitrope, a move the company hopes will lead to the launch of the first generic biologic in Europe.
Clinical investigators considering taking on sponsor responsibilities in investigator-initiated clinical trials (IITs) will need to boost their knowledge of both investigator and sponsor FDA regulations, or they could find themselves in a tangled web of compliance trouble, an FDA official said.
The FDA plans to re-inspect Andrx’s manufacturing facility to resolve good manufacturing practice (GMP) concerns, but did not indicate when it would conduct the inspection, Andrx said in a Dec. 15 SEC filing.
Voluntary codes of conduct established by industry groups to control pharmaceutical companies’ marketing practices are ineffective and routinely abused by drugmakers, contends the watchdog group Public Citizen, which yesterday released a study documenting promotional abuses at an industry convention.
The founder of Immediate Care, a home healthcare company based in Alaska, said he plans to build the state's first generic drug manufacturing plant in Anchorage.