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The FDA and OHRP appear to be responding to industry calls to coordinate their activities by issuing separate but related documents in the same week allowing exemptions from informed consent rules in clinical trials of in vitro diagnostic (IVD) devices during a public health emergency.
In a citizen petition opposing FDA approval of Sandoz’ follow-on human growth hormone Omnitrope, biotechnology firm Genentech asked the agency to notify drugmakers of any potential use of their drugs’ safety and efficacy data, a move that would stymie the agency’s efforts to draft a guidance for the manufacture of follow-on biologics.
The FDA and the HHS Office for Human Research Protections (OHRP) have responded to industry requests for harmonized regulations by issuing related guidance documents in the same week that allow informed consent waivers in clinical trials of in vitro diagnostic devices during a public health emergency.
A World Health Organization (WHO) initiative to loosen drug and diagnostic intellectual property laws for developing countries could encourage less-needy countries to invoke compulsory licensing and remove the financial incentive to develop new treatments, one industry expert told WDL.
The FDA is attempting to enable pharmaceutical regulators and industry to make more effective and consistent risk-based decisions by issuing an International Conference on Harmonisation guidance.
The FDA’s efforts to eliminate unapproved drugs from the market is more show than substance and seems to be part of an agency trend to tread lightly where industry is involved, an activist group says.
The FDA just issued an International Conference on Harmonisation (ICH) guidance intended to enable pharmaceutical regulators and industry to make more effective and consistent risk-based decisions.
The FDA has issued an International Conference on Harmonisation guidance intended to enable pharmaceutical regulators and industry to make more effective and consistent risk-based decisions.