Generic Drugs

Aug 25, 2017
By Pharmaceutical Technology Editors
The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.
Aug 04, 2017
By Pharmaceutical Technology Editors
Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.
Aug 02, 2017
Pharmaceutical Technology
FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 
Aug 01, 2017
By Pharmaceutical Technology Editors
FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.
Jul 25, 2017
By Pharmaceutical Technology Editors
The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.
Jul 12, 2017
By Pharmaceutical Technology Editors
The company has entered into a settlement agreement with generic-drug companies to resolve patent litigation.
Jul 05, 2017
By Pharmaceutical Technology Editors
A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.
Jun 27, 2017
By Pharmaceutical Technology Editors
The agency announced it is taking steps to increase competition within the prescription drug market.
Jun 23, 2017
By Pharmaceutical Technology Editors
The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.
Jun 21, 2017
By Pharmaceutical Technology Editors
FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.
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