Caraco Pharmaceutical Files Two FDA Drug Applications.

PR Newswire;  September 7, 2000 ;     277 words ...Nine Drug Applications Filed, 21 Drugs Under Development...Bulletin Board: CARA) has filed two drug applications with the U.S. Food and Drug...approvals for some of the Company's drug applications are anticipated next year. The...

FDA struggles as number of ANDAs keeps mounting.(Generic...

Chain Drug Review;  February 27, 2006 ;     301 words ......backlog of over 800 abbreviated new drug applications (ANDAS), according to a report earlier...receive a record number of generic drug applications this year, contributing to an even...FDA approved more than 450 generic drug applications--down 23 from 2004. FDA reviewers...

FDA proposes changes to provide clearer information to drug sponsors...

M2 Presswire;  July 19, 2004 ;     700+ words ......sponsors concerning reviews of their new drug applications(C)1994-2004 M2 COMMUNICATIONS LTD...complete response letters for new drug applications would be classified by what needs...terminology for resubmissions of generic drug applications. Under the proposal, a major generic...

FDA Revises Process for Responding to Drug Applications.

M2 Presswire;  July 9, 2008 ;     534 words ......Revises Process for Responding to Drug Applications(C)1994-2008 M2 COMMUNICATIONS LTD...CDER). Thorough and timely review of drug applications is a priority of the FDA, and these...approval. Currently, when assessing new drug applications, the FDA can respond to a sponsor...

Lannett Files Two New Drug Applications; In-Licenses Additional Two ANDA...

PR Newswire;  January 31, 2005 ;     427 words ......Administration (FDA) two Abbreviated New Drug Applications (ANDAs). These drug applications bring to 11 the number of ANDAs the...for these products abbreviated new drug applications will be filed. We have been active...

FDA: drug applications.(Federal Register)(Brief Article)

Older Americans Report;  November 12, 2004 ;     71 words ...FDA: Drug applications. The Food and Drug Administration issues draft guidance on the procedures for listing new drugs, including the circumstances under...

FDA REVISES PROCESS FOR RESPONDING TO DRUG APPLICATIONS

US Fed News Service, Including US State News;  July 9, 2008 ;     495 words ......Thorough and timely review of drug applications is a priority of the FDA, and these...approval. Currently, when assessing new drug applications, the FDA can respond to a sponsor...the FDA to review new or generic drug applications or biologic license applications...

The Biotechnology Industry Organization. (Update).(generic biologic drug...

Medical Marketing & Media;  June 1, 2003 ;     41 words ...The Biotechnology Industry Organization has asked the FDA to refrain from approving generic biologic drug applications. The group argues that the FDA has no authority to approve follow-on versions of such products, particularly human growth hormone and insulin.

The poor quality of some new drug applications are contributing to a rise...

Medical Marketing & Media;  June 1, 2003 ;     48 words ...The poor quality of some new drug applications are contributing to a rise in review times, FDA Office of New Drugs director John Jenkins told a Temple University School of Pharmacy...

Canada okays two Orchid drug applications

The Hindustan Times;  April 3, 2007 ;     206 words ......Tuesday announced that it has received formal approval from the Canadian Therapeutic Product Directorate (TPD) for two of its drug applications. These ANDS (Abbreviated New Drug Submission) application approvals correspond to two generic formulations, Cefoxitin and...

System to handle ANDAs electronically.(RX RETAIL PHARMACY: Generic...

Chain Drug Review;  October 23, 2006 ;     372 words ......designed to electronically review and archive abbreviated new drug applications (ANDAs). The OGD recently began using the division file...has seen a significant growth in the number of generic drug applications received, and we expect even more growth in the future...

First DataBank Releases Enhanced Drug Toolkit; Comprehensive Tool Set...

PR Newswire;  February 13, 1997 ;     567 words ......Toolkit simplifies implementation of drug applications supported by the National Drug Data...to quickly and easily deploy vital drug applications, said Dr. Joseph Hirschmann, president...demands for new and more sophisticated drug applications, said Barry Blumenfeld, M.D., Director...

HHS Rule on Supplements and Other Changes Approved New Animal Drug...

US Fed News Service, Including US State News;  February 10, 2007 ;     97 words ......Staff has transmitted, pursuant to law, the report of a rule entitled "Supplements and Other Changes Approved New Animal Drug Applications." The document (RIN0910-AF59)(Docket No. 1999N-1415) was received by the Senate on Jan. 25. For more information about...

FDA revises process for responding to drug applications.(FDA Update: A...

Pharmaceutical Processing;  August 1, 2008 ;     336 words ......M.D., director of CDER. Thorough and timely review of drug applications is a priority of the FDA, and these new processes will...application ready for approval. Currently, when assessing new drug applications, the FDA can respond to a sponsor in one of three types...

Bristol-Myers to File Drug Applications

AP Online;  November 18, 2004 ;     291 words ......AP Online 11-18-2004 Dateline: NEW YORK Bristol-Myers Squibb Co. reiterated on Wednesday it was on track to file two new drug applications by the end of the year: one for its diabetes treatment muraglitazar and the other for rheumatoid arthritis medicine abatacept...