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A major drug industry trade group has suggested the FDA abbreviate or withdraw 21 CFR Part 11 in favor of existing legislative measures to craft policy defining how drugmakers use erecords and esignatures in drug applications, biologics license submissions and other filings with the agency.
The ranking Democrat on the House Government Reform Committee has asked the FDA to release summaries of pediatric studies on the use of antidepressants and other drugs that the agency may be withholding.
Legislation that would require companies to expense the stock options of only the five highest-paid company executives was passed by the House last week — an action that delighted the biotechnology industry, which had opposed another government proposal requiring companies to expense all employee stock options.
Guidances on the clinical evaluation or approval requirements for six classes of drugs were withdrawn last week because they are out of date and of little value to the industry, according to the FDA.
To compel greater compliance with posting requirements on clinical drug trial registries, two Democratic senators are giving consideration to authorizing the FDA to withhold approval of clinical trial protocols pending a sponsor's commitment to list on the registry.
A congressional study of the likely costs of the Medicare Rx benefit revealed that they are in line with estimates Congress had relied upon when considering the original bill last year.
A provision passed by the House barring the FDA from spending federal money to block the importation of Rx drugs potentially could pave the way for counterfeiters to flood the U.S. market with fake products, according to the agency’s director of pharmacy affairs.