Author: Publisher:
ISBN:
Category :
Languages : en
Pages : 58
Book Description
United States of America V. Bhutani
Author: United States of America V. Bhutani
Author: United States Reports
Author: United States. Supreme CourtPublisher:
ISBN:
Category : Law reports, digests, etc
Languages : en
Pages : 1018
Book Description
Prosecutorial Misconduct
Author: Food, Drug, Cosmetic Law Reporter
Author: West's Federal Supplement
Author: Publisher:
ISBN:
Category : Law reports, digests, etc
Languages : en
Pages : 1838
Book Description
West's Federal Practice Digest 4th
Author: Publisher:
ISBN:
Category : Law reports, digests, etc
Languages : en
Pages : 658
Book Description
Internal Corporate Investigations
Author: Barry F. McNeilPublisher: American Bar Association
ISBN: 9781590319154
Category : Business & Economics
Languages : en
Pages : 550
Book Description
In the wake of highly publicized corporate shake-ups, internal investigations have gained national prominence and established themselves as an important tool of management. This newly updated and expanded resource guides you through the intricate steps of conducting an effective and efficient internal investigation. Each chapter covers one aspect of conducting an investigation, clearly describing and advising you on the methods and skills involved, while providing you with practical tips on anticipating, recognizing, and avoiding the traps you are certain to encounter.
Generic and Innovator Drugs
Author: Donald O. BeersPublisher: Wolters Kluwer
ISBN: 1454836091
Category : Law
Languages : en
Pages : 2154
Book Description
Completely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process. Youand’ll find comprehensive coverage of: Abbreviated new drug applications 505(b)(2) new drug applications Delaying approval of competing products FDA approval of biologic drugs No other book can cover the drug approval process as thoroughly, answering important questions like these: What is required to extend the patent of an FDA-approved product? When must a generic manufacturer notify the innovator manufacturer when submitting an ANDA or 505(b)(2) application? When does the FDA delay approvals because of patent claims, and when does it ignore patents? How can one challenge an FDA exclusivity decision? When can a manufacturer safely sell a drug without prior FDA approval? In what circumstances can a generic manufacturer obtain FDA permission to file an ANDA for a variant of an existing drug? When will the FDA waive or reduce prescription drug user fees? How can a company or an individual avoid debarment? What steps are necessary to comply with the FDAand’s Fraud Policy? When and how can a drug company take advantage of FDA accelerated approval procedures? What are the labeling requirements for exporting approved drugs? How have the changes made by the FDA Safety and Innovation Act, including the Prescription Drug User Fee Act, the Generic Drug User Fee Amendments and the Biosimilars User Fee Act, and the Generating Antibiotic Incentives Now Act affected the overall statutory scheme? Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition provides step-by-step guidance of the approval process and expert interpretation of: The Hatch-Waxman Act (Drug Price Competition and Patent Restoration Act) The Medicare Prescription Drug, Improvement, and Modernization Act The Food and Drug Administration Modernization Act The FDA Export Reform and Enhancement Act The Biologics Price Competition and Innovation Act And more! AUTHOR NOTE Donald O. Beersand’ contributions to this publication were completed before he rejoined the Food and Drug Administration. He has had no part in writing and revising this Eighth Edition.
West's Federal Practice Digest
Author: Publisher:
ISBN:
Category : Law reports, digests, etc
Languages : en
Pages : 650
Book Description