Standards/Regulations

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.
Dec 18, 2017
By Pharmaceutical Technology Editors
The agency has proposed a risk-based enforcement approach to protecting patients against unproven homeopathic drugs.
Dec 18, 2017
By Pharmaceutical Technology Editors
The draft guidance provides guidance on the development of drugs and biologics in which a nanomaterial is present in the finished dosage form.
Dec 12, 2017
The authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.
Dec 07, 2017
An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.
Dec 05, 2017
By Pharmaceutical Technology Editors
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
Nov 27, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
Manufacturers and trading partners struggle to meet drug tracking requirements
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