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While the FDA’s promulgation of three draft guidance documents on risk assessment and minimization will go a long way to establishing a framework for industry and the agency, some components of the guidances may actually delay the availability of new and beneficial drugs, according to PhRMA.
Generic firm Mylan Laboratories will likely sue the FDA over the agency’s refusal to prohibit the marketing and distribution of authorized generics until after the first generic firm’s 180-day exclusivity period has expired.
Delays by pharmaceutical manufacturers in reporting the results of clinical drug trials to a federal government website have led several senators to call for the creation of a national registry of drug trials that would considerably expand the scope of the existing database at clinicaltrials.gov.
The Center for Devices and Radiological Health recently issued a public request for nominations for nonvoting industry representatives to sit on its Medical Devices Advisory Committee panels.
A pilot program launched by the FDA and the Global Harmonization Task Force (GHTF) to provide a streamlined alternative to the complex process of international premarket filings has been extended for a second year, according to a July 8 Federal Register notice.
The FDA recently issued a warning letter to a Virginia device manufacturer for failing to implement numerous procedural sections of the quality system regulation (QSR).
Federal authorities filed a civil lawsuit June 25 to seize approximately 26 patient lifts from an Illinois distributor after the firm allegedly failed to disclose to the FDA that a faulty lift resulted in a patient death.
Guidant confirmed July 1 that its drug-eluting Champion stent will face a six- to eight-month delay to correct a stent platform flaw, but will require no additional clinical data to satisfy FDA regulators.