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News
Bioequivalence
Feb 26, 2020
Pharmaceutical Dissolution Testing Workshop - Focus on Solid Oral Dosage Forms | Boston, MA, United States - June 8th-10th, 2020
Feb 24, 2020
FDA approves first generic of ProAir HFA
Jan 16, 2020
Two-Day Annual Dry Powder Inhalers Conference; Covering INFORM 2020, The 1nhaler, and More | London, United Kingdom - June 24th-25th, 2020
Oct 31, 2019
Pharmascience Inc. launches pms-FINGOLIMOD for the treatment of relapsing-remitting multiple sclerosis (MS) in adults
Oct 09, 2019
Absorption Systems Awarded 5-year IDIQ Contract by the U.S. Food and Drug Administration
Aug 21, 2019
SAAMnow Holding Fall Workshop on 505(b)(2)s
Jul 19, 2019
Biohaven's Nurtec (riluzole) 505(b)2 Application for Amyotrophic Lateral Sclerosis Affected by Issues Related to Apotex Plant: Complete Response Letter (CRL) Received From FDA Related to Isolated Drug Substance Supply Used in Bioequivalence Study
May 29, 2019
Former FDA Associate Director, Office of Epidemiology & Biostatistics (CDER), William Fairweather, PhD, PSTAT, Joins NDA Partners
May 23, 2019
Dry Powder Inhalers: Key Annual Conference for Pharmaceutical and Medical Device Professionals - London, United Kingdom - June 19-20, 2019
Feb 25, 2019
FDA In Brief: To improve drug safety and effectiveness, FDA issues new guidelines on evaluating the absorption of drugs in the body, including the effect of eating certain foods on drug efficacy
Dec 12, 2018
NDA Partners Expert Consultant Vinod Shah, PhD, Receives AAPS Award for Global Leadership
Nov 16, 2018
Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials
Oct 09, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines
Sep 09, 2018
Xspray Pharma Announces Positive Clinical Data for Its Lead Product Candidate HyNap-Dasa
Sep 04, 2018
Japanese Patent Granted for Absorption Systems' IDAS2(TM), a Uniquely Predictive Test System for Fundamental Drug Properties
Jul 04, 2018
Pharmascience Inc. launches (Pr)pms-TRANDOLAPRIL, first generic bioequivalent to (Pr)MAVIK® available on the market, for the treatment of mild to moderate essential hypertension
May 31, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access
May 29, 2018
Why the Russian Pharmaceutical Market is Attractive for Foreign Generics, ARS PharmRussia Explains
May 17, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition
Jan 16, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA's ongoing efforts to increase access to complex generic drugs
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