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The FDA is asking sponsors of INDs, NDAs and NDA supplements to submit bioavailability and bioequivalency data from pharmacokinetic studies of their products. Read More
Drugmakers balked at the FDA’s push for sponsors of new chronic pain treatments to submit more safety data, calling it inconsistent and confusing. Read More
The FDA should incentivize sponsors to include minorities and other underrepresented groups in clinical trials and delay approving products whose evidence is based on less-inclusive trials, activists say. Read More
Sponsors of BLAs, NDAs, and ANDAs should justify the amount of excess medication for injectable drug products they plan to pack in vials and ampules, according to an FDA draft guidance. Read More
In a bid to cut down on orphan drug developers wasting agency time, the FDA is outlining new, detailed guidelines for what constitutes a legitimate topic for formal and informal presubmission meetings. Read More
The European Medicines Agency is planning a series of May meetings with industry to unveil the process it plans to use to determine whether clinical trial data is considered confidential under its new transparency rules or whether it must be disclosed. Read More
Unlike in the EU, Swiss regulators will not accept marketing authorization applications for biosimilars of low-molecular-weight heparin products already approved in Switzerland. Read More
The EU’s primary biotech lobbying group is pushing back against same-name biosimilars, arguing that physicians would find such a system confusing. Read More
The FDA wants manufacturers of low molecular weight heparin (LMWH) products to do a better job of assessing immunogenicity risk before submitting their products for approval. Read More
Drugmakers seeking variations to marketing authorizations in the EU will now have a point person assigned to usher their applications through the evaluation process, the European Medicines Agency says. Read More
The FDA needs to hold more presubmission meetings with generic drugmakers on topics such as stability, batch size and drug release specifications to speed up the ANDA approval process, industry representatives say. Read More
The FDA is continuing its push to find ways to curtail opioid abuse, calling for suggestions and recommendations on innovative packaging, storage and disposal systems, technologies or designs that would thwart abusers. Read More