Standards & Regulations

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.
Jan 24, 2018
By Pharmaceutical Technology Editors
The agencies sent warning letters to several companies that the agencies say are illegally marketing unapproved products to treat opioid addiction and withdrawal.
Jan 24, 2018
Viewpoint: The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation.
Dec 20, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.
Dec 19, 2017
By Pharmaceutical Technology Editors
EMA recommends suspending the marketing of modified- or prolonged-released products containing paracetamol due to a difficulty in managing overdose.
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