Standards & Regulations

Mar 02, 2018
Pharmaceutical Technology
Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.
Mar 02, 2018
Pharmaceutical Technology
The upcoming serialization deadline and the United Kingdom's departure from the European Union could result in supply bottlenecks.
Feb 23, 2018
By Pharmaceutical Technology Editors
The agency clarifies recommendations found in ICH Q11 about chemical entities and biotechnology entities.
Feb 21, 2018
By Pharmaceutical Technology Editors
Divinity Products Distribution of Grain Valley has voluntarily agreed to destroy and recall kratom-containing dietary supplements as part of FDA's crackdown on the plant.
Feb 21, 2018
By Pharmaceutical Technology Editors
The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.
Feb 15, 2018
By Pharmaceutical Technology Editors
The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.
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.
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