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The FDA is revising its drug and biologics application guidance to discuss the evolving science of drug-to-drug interactions and changes to labeling requirements.
The FDA is updating its current drug and biologics application guidance to discuss the evolving science of drug-to-drug interactions and changes to labeling requirements.
Manufacturers of at-home medical devices should consider the unique human factors involved in using such devices, or face the risk of liability lawsuits.
Industry is concerned that U.S. FDA recommendations on genetic test premarket approval (PMA) and 510(k) applications may be overly burdensome and restrictive.
The U.S. FDA Aug. 3 posted guidance on how device firms can qualify for small business user-fee discounts and waivers for agency reviews of their products under the Medical Device User Fee and Modernization Act (MDUFMA) in fiscal 2007.
The Therapeutic Goods Administration (TGA) has developed new guidance on registering Class III and active implantable medical device variants in the Australian Register of Therapeutic Goods (ARTG).
The FDA may be making life easier for researchers conducting studies in emergency settings when patients are unable to give their informed consent, issuing a draft guidance on informed consent
exceptions Aug. 29.
The FDA published its annual guidance document agenda and is seeking public comments on possible topics for future guidance development and revisions to existing documents.