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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Bioequivalence guidance accessibility: FDA has released draft guidance regarding the agency's plans to make product-specific, bioequivalence study ...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
- 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...
- 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.
- News wire article from: Chemical Business Newsbase 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 15 Dec 2008 that shifts away from a showing of rapid dissolution as originally proposed by FDA's Office...
- 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...
- DURAMED OPTIMISTIC AFTER FDA ADVISORY COMMITTEE MEETING ON CONJUGATED ESTROGENS
- Press release article from: PR Newswire July 31, 1995 700+ words
...Fertility and Maternal Health Drugs and Generic Drugs Advisory Committees made clear on July 28 that the 1991 bioequivalence guidance which establishes the scientific basis for ingredient requirements of conjugated estrogens will stand," Mr...
- DURAMED REPORTS SECOND QUARTER RESULTS FOR 1995
- Press release article from: PR Newswire August 7, 1995 700+ words
...recent action by the Fertility and Maternal Health Drugs and Generic Drugs Advisory Committees reaffirms the bioequivalence guidance for conjugated estrogens established by the FDA in 1991. With this recent development, we remain confident...
- Bioequivalency rules sought.
- Magazine article from: Chain Drug Review June 23, 1997 700+ words
...osteoporosis, convincing the agency to reclassify the ingredient as a concomitant component. The ruling that the bioequivalence guidance for conjugated estrogens should be reexamined even divided FDA regulators. But for Burr chairman, president...
Source: HighBeam Research, Bioequivalence guidance accessibility.(NOTED)