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The FDA’s Office of Generic Drugs (OGD) has announced it will post a dissolution-methods database online and update the Orange Book daily to assist generic firms improve the quality of their drug applications.
The FDA has issued warning letters to 23 companies that manufacture and distribute products containing androstenedione, a steroid precursor that has become popular among professional and amateur athletes.
After issuing a final rule earlier this year banning dietary supplements containing ephedra, the FDA focused its efforts yesterday on taking the steroid precursor androstenedione, also known as andro, off the market by issuing warning letters to 23 companies manufacturing and distributing andro products.
As part of an ongoing effort to help firms improve the quality of their generic drug applications, the FDA’s Office of Generic Drugs (OGD) will soon post a dissolution-methods database on its website and start updating the Orange Book daily.
More than half of the participating product review divisions in the FDA's Center for Drug Evaluation and Research (CDER) are still accepting submissions for a pilot program that will assess the effectiveness of continuous marketing applications for fast-track designated drugs, the agency announced recently.
The FDA will continue working with industry to refine the process for electronic filing of promotional materials rather than issue additional guidances on the subject, a top FDA official told FDL recently.
The FDA is taking a measured approach to direct-to-consumer (DTC) advertising by tackling drug labeling guidelines before taking on rules for internet promotions, despite calls from industry for guidance on web-based marketing.
Even as it streamlines its processes for reviewing ads through simplified patient labeling requirements and electronic filing of promotional materials, FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) concedes it is unable to thoroughly review each submission.
One Democratic senator is vowing to delay the confirmation of FDA Commissioner Mark McClellan as head of the Centers for Medicare & Medicaid Services, even though the Senate Finance Committee approved the nomination yesterday and sent it to the Senate floor for confirmation.
In a final rule that is expected to cost the drug industry $28.1 million in the first two years of implementation, the FDA is requiring drugmakers to include linear bar codes on the labels of most prescription drug products commonly used in hospitals and other healthcare settings.