Standards/Regulations

Feb 14, 2018
By Pharmaceutical Technology Editors
The agency provides information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms.
Feb 14, 2018
The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.
Feb 12, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.
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 07, 2018
By Pharmaceutical Technology Editors
The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.
Feb 02, 2018
Pharmaceutical Technology
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, according to Susan Schniepp, fellow at Regulatory Compliance Associates.
Feb 02, 2018
Pharmaceutical Technology
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
Feb 02, 2018
Pharmaceutical Technology
Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.
Feb 01, 2018
Pharmaceutical Technology
CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.
Jan 31, 2018
FDA and industry weigh broader use of prior knowledge in biotechnology testing and production.
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