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Bioequivalence guidance accessibility.(NOTED)
Bioequivalence guidance accessibility: FDA has released draft guidance regarding the agency's plans to make product-specific, bioequivalence study ...
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- ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance.
- Press release article from: PR Newswire March 18, 2009 700+ words
- Company Calls for Additional Scientific Data and Withdrawal of Guidance - EXTON, Pa., March 18 /PRNewswire-FirstCall/ -- ViroPharma Incorporated today announced its submission to the U.S. Food and Drug Administration (FDA) of comments on FDA's Office of Generic Drugs' (OGD) December 2008 draft
- ViroPharma Announces Meeting of FDA Advisory Committee for Pharmaceutical...
- Press release article from: PR Newswire May 29, 2009 700+ words
...ViroPharma's efforts to oppose the FDA's December 2008 bioequivalence guidance for Vancocin through in vitro dissolution testing will...If we are unable to change the FDA's December 2008 bioequivalence guidance for Vancocin, the threat of generic competition will...
- DURAMED REPORTS FIRST QUARTER RESULTS FOR 1995
- Press release article from: PR Newswire May 10, 1995 700+ words
...estrogens. Nothing has happened that has caused us to change our belief that our product meets the current bioequivalence guidance established by the FDA in 1991. We remain confident in our ANDA submission and we intend to respond to all...
- DURAMED AND SCHEIN SIGN LETTER OF INTENT FOR CONJUGATED ESTROGENS DEVELOPMENT
- Press release article from: PR Newswire March 2, 1992 700+ words
...Tablets, the generic equivalent to the brand product Premarin. This new formulation will be designed to meet bioequivalence guidance established by the FDA in late 1991. Under the agreement, Schein will provide project funding and technical...
- ViroPharma Files FOIA Complaint Seeking Administrative Record for Vancocin(R).
- Press release article from: PR Newswire December 18, 2008 700+ words
...action, ViroPharma submitted a FOIA request to FDA for the administrative record relating to FDA's Vancocin bioequivalence guidance of December 15, 2008 that shifts away from a showing of "rapid" dissolution as originally proposed by FDA...
- DRUGMAKER DURAMED LAYS OFF 94.(BUSINESS)
- Newspaper article from: The Cincinnati Post (Cincinnati, OH) Peale, Cliff October 31, 1996 700+ words
...osteoporosis. ''We have yet to see any information that we believe would compel the agency to change the existing bioequivalence guidance for generic conjugated estrogens,'' Arington said. ''If the agency follows its existing guidance, we...
- DURAMED RESPONDS TO DORFMAN COMMENTS ON CNBC
- Press release article from: PR Newswire August 22, 1995 700+ words
...industry partners has further strengthened the company. "The FDA Advisory Committee made clear in July that the bioequivalence guidance which established the scientific basis for ingredient requirements of conjugated estrogens will stand," Mr...
- DURAMED AND SCHEIN COMPLETE AGREEMENT FOR CONJUGATED ESTROGENS DEVELOPMENT
- Press release article from: PR Newswire June 29, 1992 700+ words
...pursuant to the letter of intent announced on March 2, 1992. This new formulation is being designed to meet bioequivalence guidance established by the Food and Drug Administration (FDA) in late 1991. Under the agreement, Schein will provide...