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November 26, 2008
The US Food and Drug Administration issued a draft guidance, Contents of a Complete Submission for the Evaluation of Proprietary Names, on Nov. 24, 2008.
November 20, 2008
The US Food and Drug issued a draft guidance on Tuesday, Nov. 18, titled Process Validation: General Principles and Practices for comment. The guidance is meant to serve as a revision to the 1987 Guideline on General Principles of Process Validation.
October 23, 2008
The US Food and Drug Administration released a draft guidance that reviews the agency's plan to offer priority-review vouchers to companies developing new treatments for neglected tropical diseases.
August 14, 2008
The US Food and Drug Administration issued a new draft guidance for public comment on sterile manufacturing.
The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment.
July 17, 2008
Bristol-Myers Squibb (BMS) agreed to reduce the output of ozone-depleting refrigerants at several industrial facilities around the country to resolve violations of the Clean Air Act. The company's modifications will cost approximately $3.65 million.
The US Food and Drug Administration published a Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format in the Federal Register on July 11.
July 10, 2008
Pfizer has agreed to pay $975,000 in civil penalties to resolve alleged violations of the Clean Air Act at its former manufacturing plant in Groton, Connecticut, according to a release by the US Department of Justice.
The European Pharmacopeia Commission has published the General Information chapter "Potentially Genotoxic Impurities and European Pharmacopoeia Monographs on Substances for Human Use" in the July 2008 edition of PharmEuropa.
June 05, 2008
The US Food and Drug Administration issued a new guidance Monday on indexing structured product labeling. The Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research will begin indexing structured product labeling in the product labeling for human drug and biologic products.