By Douglas J. Pisano, David S. Mantus
Examines harmonization of the USA Federal nutrients, Drug, and beauty Act with overseas laws as they observe to human drug and gadget improvement, examine, production, and advertising. The Second Edition makes a speciality of the recent drug approval procedure, cGMPs, GCPs, caliber approach compliance, and corresponding documentation requisites. Written in a jargon-free kind, it attracts info from a variety of assets. It demystifies the internal workings of the FDA and enables an figuring out of the way it operates with admire to compliance and product approval.
FDA Regulatory Affairs:
- provides a blueprint to the FDA and drug, biologic, and scientific machine development
- offers present, real-time details in an easy and concise format
- contains a bankruptcy highlighting the hot drug software (NDA) process
- discusses FDA inspection methods and enforcement options
- includes contributions from specialists at businesses resembling Millennium and Genzyme, top CRO’s similar to PAREXEL and the Biologics Consulting team, and the FDA
Three all-new chapters cover:
- clinical trial exemptions
- advisory committees
- provisions for speedy track
Read Online or Download FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics PDF
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Extra resources for FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics
Most issues and questions usually are related to the design of animal studies needed to initiate clinical trials as well as the scope and design of the initial study in humans. Type B meetings should be scheduled to occur within 60 days of the FDA’s receipt of the written request for the meeting. A briefing document is required at least four weeks before the meeting. The briefing document should provide summary information relevant to the product and supplementary information that the FDA can use to provide responses to the questions that have been identified by the sponsor for the IND submission.
The initial IND application to the FDA can be for a phase 1 first in human study, or it can be for a later-phase study where clinical studies of the compound have already been conducted in another country. Although the basic content is the same, the expected level of detail is different. The information expected in later-phase studies is based on the phase of investigation, the amount of human experience with the drug, the drug substance, and the dosage form of the drug. In the outline, requirements will be addressed both for INDs for phase 1 studies as well as initial INDs for later-stage studies.
All information must be truthful and not misleading. All material facts must be disclosed in a manner that is fairly balanced and accurate. If any of these requirements are violated, the product is considered misbranded for the indications for which it was approved under its NDA. FDA 62 21 USC Sec 321(h). ” Off-label use occurs when a product is in some way presented in a manner that does not agree with or is not addressed in its approved labeling. Also, provisions of the Prescription Drug Marketing Act (PDMA) of 1987 apply.