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New Drug Application Submissions

MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation and Research DATE: January 29, 1999 FROM: David Isom, Directo Office of Information Technology CDER, HFD-070 SUBJECT: Docket 925-0251- Update Transmittal TO: Chief, Dockets Management Branch, HFA-305 Pursuant to ... more>>

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Investigational New Drug Applications New Drug Applications Biologics Licensing Applications Abbreviated New Drug Applications Master Files Annual Reports

I~T~ UALTHAAND HUMAN AN SERVICE S ~ MEMORANDUM DBPART ~C AL~ ' FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation and Researc h DATE : FROM : James Shugars , Director Office of information Te ology CDER, HFD- 07 0 SUBJECT : TO : Docket 92S-0251 - Transmittal Chief, Dockets M anagement Branch , HFA-305 Pursuant to 21 CFR Part 11 .2(b) (2), ... more>>

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U S Food and Drug Administration Regulation

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Safety of food and feed

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DEPARTMENT OF HEALTH HUMAN SERVICES Food and Drug Selected Enforcement Actions onUnapproved Drugs

DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Rockville, MD 20857 WARNING LETTER October 11, 2002 Mr. John Q. Adams Product: Humibid Capsules Pediatric 300 mg Dear Sir/Madam: This letter is written in reference to the marketing by your firm of Humibid Capsules Pediatric 300 mg, a single ingredient guaifenesin extended releas ... more>>

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Repeal of Section of the Federal Food Drug and Cosmetic Act

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Division of Oncology Drug Products

Outline for Performing NDA Review Susan Honig, Division of Oncology Drug Products Page # Objectives of the Review 1.0 InitialOrganization 2.0 Summary of Non-clinical disciplines 2.1 Regulatory Review 3.0 Review First Pivotal Trial 4.0 Other Clinical Trials and Non-Clinical Issues 5.0 Summary of Safety and Efficacy 6.0 Oncologic Drugs ... more>>

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Drug Information Association Information Technology Initiatives in Drug Registration Submissions January

I In Cooperation With: Overview The U.S. Food and Drug Administrationhas undertaken manyInforma- The U.S. Food andDrug Administration and PhRMA Program Chairpersons: Krishan K. Arora, PhD, International irector, D ElectronicSubmissions, rug RegulatoryAffairs D Novartis Pharmaceuticals Corporation David C. Isom, Acting Director, Office of Inf ... more>>

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DEPARTMENT OF HEALTH HUMAN SERVICES Food and Drug

DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Rockviile MD 20857 I UEC Q98 18 . CERTIFIED MAIL RETURN RECEIPT REQUESTED WARNING LETTER Dr. Alex Krauer Chairman of the Board Novartis AG Postfach CH-4002 Basel, Switzerland from the During the period of August 24-28, 1998, an investigator U.S. Food and Drug Administration cond ... more>>