Generic Drugs

Jul 19, 2018
In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.
Jun 22, 2018
By Pharmaceutical Technology Editors
FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.
Jun 22, 2018
By Pharmaceutical Technology Editors
The approval is intended to increase patient access to treatment for opioid addiction.
Jun 22, 2018
By Pharmaceutical Technology Editors
The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.
Jun 13, 2018
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
Cambrex expands its generic API research and development capabilities at its Milan, Italy site.
May 31, 2018
By Pharmaceutical Technology Editors
The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.
May 17, 2018
By Pharmaceutical Technology Editors
Internationalization and regulatory reform are driving growth and investment China.
May 17, 2018
By Pharmaceutical Technology Editors
The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.
Feb 08, 2018
Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.
Feb 02, 2018
Pharmaceutical Technology
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
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