Standards & Regulations

Feb 15, 2018
By BioPharm International Editors
FDA Commissioner Scott Gottlieb issued a statement that FDA will be modernizing regulatory programs in order to advance novel treatments.
Feb 14, 2018
The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.
Feb 12, 2018
By BioPharm International 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 BioPharm International Editors
The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.
Feb 07, 2018
By BioPharm International Editors
The agency met to discuss its new temporary and permanent premises in Amsterdam.
Feb 01, 2018
BioPharm International
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 01, 2018
The President described US drug costs as unfair and stated that prices will come down.
Jan 31, 2018
FDA and industry weigh broader use of prior knowledge in biotechnology testing and production.
Jan 24, 2018
By BioPharm International Editors
The agencies sent warning letters to several companies that the agencies say are illegally marketing unapproved products to treat opioid addiction and withdrawal.
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