Synopsis
This Fifth Edition provides a complete reference to significant developments in FDA approval requirements, including extensive coverage of innovator drugs, the drug approval process and patent term extension. Plus, it includes the full text of relevant statutes, regulations, FDA guidelines, memoranda, correspondence, and more. This publication is an invaluable reference for drug company officials, regulatory affairs staffs, and legal counsel. This one-volume guide contains exhaustive discussions and analyses of all the major regulatory and legal actions from the 1938 FDCA grandfather clause through the latest amendments to the Federal Food, Drug, and Cosmetic Act. Major topics covered include: FDA approval requirements
-- Full new drug applications
-- Abbreviated new drug applications and paper ANDAs
-- Delaying approval of competitive products
-- Public availability of NDA data
-- The orphan drug amendments
-- Debarment
-- FDA fraud policy
-- Accelerated approvals
-- And more.
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Generic and Innovator Drugs: A Guide to Fda Approval Requirements
Seller: Amazing Books Pittsburgh, Pittsburgh, PA, U.S.A.
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hardcover. Condition: Very Good. FIfth. Book is in great condition, some very light wear on edges of cover and pages. Fifth Edition. Hardcover. LW. Seller Inventory # D22422