Compliance Regulations and Guidance Affecting your Industry
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By - Roger Cowan
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By - Doug Keipper
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By - Joy McElroy
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By - Carolyn Troiano
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By - Dr. Afsaneh Motamed Khorasani
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Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applicatio ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs and ANADA.
Effective Date :This rule is effective August 3, 2009
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applicatio ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs and ANADA.
Applications for Food and Drug Administration Approval To Market a New Drug: Postmarketing Repo ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly.
