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Drugmakers will have 30 days instead of the originally proposed 10 days to formally challenge scientific and technical issues observed during FDA current good manufacturing practice (cGMP) inspections, according to a final guidance released by the agency Jan. 11.
The fundamental reason for clinical trial sponsors to establish data monitoring committees (DMCs) is to enhance the safety of participants when safety concerns are unusually high, according to a recent FDA draft guidance that helps sponsors determine when DMCs are needed and how such committees should operate.
The FDA’s regulatory project managers will continue to tour industry manufacturing sites in order to give them a better understanding of drugmakers’ operations, the agency said in a Dec. 29, 2005, notice.
FDA’s recently established Critical Path Institute (C-Path), which aims to improve the efficiency and safety of medical product development, will benefit drug, device and combination product manufacturers, according to the institute’s director and agency officials.
The FDA’s new guidance offering questions and answers on the structured product labeling (SPL) standard for labeling provides general help but lacks specifics such as templates to better assist regulated firms working to implement the new standard, experts tell PIR.
Voluntary codes of conduct established by industry groups to control pharmaceutical companies' marketing practices are ineffective and routinely abused by drug makers, contends the watchdog group Public Citizen, which recently released a study documenting promotional abuses at an industry convention.
U.S. Pharmacopeia’s (USP) recent decision to exclude a new Medicare Part D drug policy requiring broader coverage in its revised formulary guidelines makes it easier for the government to drop this policy and may necessitate a legislative fix, according to a key Senate staffer.
Drug manufacturers that provide vaccines for government stockpiles can recognize revenue from the sales immediately instead of having to wait to book the sales until the drugs are distributed, according to the SEC.
Drug manufacturers that provide vaccines for government stockpiles can recognize revenue from the sales immediately instead of having to wait to book the sales until the drugs are distributed, according to the SEC.