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While the FDA’s promulgation of three draft guidance documents on risk assessment and minimization will go a long way to establishing a framework for industry and the agency, some components of the guidances may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.
Final action on a rule governing labeling for human prescription drugs is set for October, according to the FDA’s Semiannual Regulatory Agenda, published in the Federal Register earlier this week.
The flow of illegally imported Rx drugs into the U.S. will increase if drug importation bills now being considered in Congress do not include a number of safeguards and adequate financial resources for regulatory bodies, participants at a National Association of Boards of Pharmacy (NABP) news conference said June 23.
A revised version of ISO 14969 will be published within the next month, providing guidance on implementing the quality management aspects of ISO 13485:2003, according to a member of the working group that revised the standard.
Pharmaceutical companies and other organizations conducting clinical trials are facing a widening array of obstacles on both the regulatory and legal fronts, according to experts who spoke last week at the Drug Information Association's annual meeting in Washington, D.C.
The FDA is looking for ways to increase compliance with a law mandating that companies engaged in clinical trials of drugs for serious or life-threatening diseases post notices about study data on a federal website.