+ Site Statistics
References:
54,258,434
Abstracts:
29,560,870
PMIDs:
28,072,757
+ Search Articles
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ PDF Full Text
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Translate
+ Recently Requested

Policy on 180-day marketing exclusivity for drugs marketed under abbreviated new drug applications; clarification--FDA. Clarification



Policy on 180-day marketing exclusivity for drugs marketed under abbreviated new drug applications; clarification--FDA. Clarification



Federal Register 62(229): 63268-9



The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is publishing this document to clarify the status of its practices governing 180 days of marketing exclusivity for generic drugs and the approval of abbreviated new drug applications (ANDA's) subject to patent litigation. This document is being published due to recent court decisions interpreting provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments).

(PDF emailed within 1 workday: $29.90)

Accession: 047006206

Download citation: RISBibTeXText

PMID: 10177950


Related references

Delayed clarification: information, clarification and ethical decisions in critical care in Norway. Journal of Advanced Nursing 32(6): 1485-1491, 2001

Clarification of suspensions: a study of particle deposition in granular media: Part IIA theory of clarification. Chemical Engineering Science 20(10): 875-888, 1965

Pectic enzymes in the clarification of apple juice. I. Study on the clarification reaction in a simplified model. Agr Biol Chem 28(11): 779-787, 1964

Minimizing energy in clarification plants and environment related treatment and removal of clarification sludge and waste. 1981

Pectic enzymes in the clarification of apple juice. II. The mechanism of clarification. Agr Biol Chem 31(5): 552-560, 1967

Experiments for developing selective clarification techniques: Sterol and fatty acid loss from grape must related to clarification technique. Journal of Wine Research 8(3): 187-197, 1997

The effect of a value clarification program on value clarification in juvenile delinquents. Taehan Kanho Hakhoe Chi 35(7): 1201-1209, 2006

Divergently Seeking Clarification: The Emergence of Clarification Interaction. Topics in Cognitive Science 10(2): 335-366, 2018

Synthesis of flocculant aids for cane sugar juice clarification: Part II - Dependence of clarification efficiency on intrinsic viscosity of cationic homopolymer. Zuckerindustrie 126(4): 259-263, 2001

Reduced clarification factor and clarification factor X clarification efficiency. Indian sugar: 26 (11) 747-751, 1977

Compositions uses and methods creating reverse micelles for the clarification of biological fluids to obtain undistorted assay of analytes following clarification us patent 4608347. aug. 26 1986. Official Gazette of the United States Patent & Trademark Office Patents 1069(4): 1730, 1986

Synthesis of flocculant aids for cane sugar juice clarification - Part III: Dependence of clarification efficiency on the composition of copolymers of acrylamide and trimethylammoniumethyl(meth)acrylate chlorides. Zuckerindustrie 126(12): 951-955, 2001

Postoperative hemorrhage after tonsillectomy. Clarification procedure of the federal court Hagen-71 Js 565/96-(implementing the clarification procedure according to section 170 Abs. 2 StPO). Laryngo- Rhino- Otologie 78(5): 293-294, 1999

Patient clarification/pre-operative clarification. Der Chirurg; Zeitschrift für Alle Gebiete der Operativen Medizen 81(2): 167-72; Quiz 173, 2010

Patent and Plant Variety Protection Remedy Clarification Act and the Trademark Remedy Clarification Act. 1992