Simplifying Global Compliance
Items Tagged with 'FDA'
The Patient Advocacy Council, a Alabama-based commercial institutional review board (IRB), is disputing an FDA warning letter accusing it of failing to protect "economically and educationally disadvantaged subjects" in clinical trials it oversaw. Read More
The FDA has issued a not approvable letter for Merck's Vioxx successor Arcoxia, telling the company it will require additional data to support the risk-benefit profile of the drug. Read More
The FDA has announced the availability of audio broadcasts on emerging drug safety information. Read More
FDA has barred all approvals for generic versions of Pfizer's Norvasc except for one issued earlier to Mylan, the agency announced in a notice to the U.S. District Court for the District of Columbia. Read More
The FDA should have more power to force manufacturers to make labeling changes and conduct postmarketing clinical studies, a trade association of leading insurers said in recent recommendations. Read More
The FDA sent Wyeth an approvable letter for its postmenopausal osteoporosis prevention product, bazedoxifene, April 24. Read More
The FDA approved 13 different abbreviated new drug applications for generic Ambien, the agency announced. Read More
Decisions on banning imported products can be based on a variety of factors, so companies must be prepared to challenge an import hold with the FDA, industry experts said at an FDAnews audioconference. Read More
The FDA released a white paper saying it has the ability to approve follow-on biologics without extensive clinical trials, although some trials would be necessary for the follow-ons to replace original products. Read More
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