Examines harmonization of the USA Federal meals, Drug, and beauty Act with overseas rules as they practice to human drug and machine improvement, learn, production, and advertising. the second one version makes a speciality of the hot drug approval procedure, cGMPs, GCPs, caliber process compliance, and corresponding documentation necessities. Written in a jargon-free kind, it attracts details from a variety of assets. It demystifies the interior workings of the FDA and allows an figuring out of the way it operates with appreciate to compliance and product approval.

FDA Regulatory Affairs:

provides a blueprint to the FDA and drug, biologic, and clinical equipment development
offers present, real-time details in an easy and concise format
contains a bankruptcy highlighting the recent drug program (NDA) process
discusses FDA inspection techniques and enforcement options
includes contributions from specialists at businesses akin to Millennium and Genzyme, major CRO’s similar to PAREXEL and the Biologics Consulting workforce, and the FDA

Three all-new chapters cover:

clinical trial exemptions
advisory committees
provisions for quick track

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Extra resources for FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics (2nd Edition)

Example text

PHASE IV AND POSTMARKETING SURVEILLANCE Pharmaceutical companies who successfully gain marketing approval for their products are not exempted from further regulatory requirements. In addition to the extensive postmarketing changes made by the Acts of 2007, compliance efforts take center stage. All producers must be registered and inspected, file various safety reports, meet import and export requirements, and maintain cGMPs. Many products are approved for market on the basis of a continued submission of clinical research data to the FDA.

39 See 21 CFR Part 58. 40 Pinna K, Pines W. The DRUGS/BIOLOGICS APPROVAL PROCESS. A Practical Guide to Food and Drug Law and Regulation. Washington, DC: FDLI, 1998:98. Overview of FDA and Drug Development 21 The sponsor will submit the IND to the FDA. The IND must contain information and information of the study on the compound itself. All INDs must have the same basic components: a detailed cover sheet, a table of contents, an introductory statement and basic investigative plan, an investigator’s brochure, comprehensive investigation protocols, the compound’s actual or proposed chemistry, manufacturing and controls, any pharmacology and toxicology information, any previous human experience with the compound, and any other pertinent information the FDA deems necessary.

Because agency review of the 300,000 plus OTC drug products in existence at the time would be virtually impossible, the FDA created OTC advisory panels to review data based on some 26 therapeutic categories. OTC drugs would only be examined by active ingredient within a therapeutic category. Inactive ingredients would only be examined, provided they were shown to be safe and suitable for the product and not interfering with effectiveness and quality. This review of active ingredients would result in the promulgation of a regulation or a monograph, which is a “recipe” or set of guidelines applicable to all OTC products within a therapeutic category.

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