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January 02, 2020
Pressures on FDA will affect industry’s success in bringing new therapies to market.
FDA sent a warning letter to GPT Pharmaceuticals Pvt. Ltd. after inspectors found CGMP violations that included equipment that was not properly maintained.
FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.
In 2020, European regulators are expected to start to be even more active in encouraging drugs innovations rather than hindering them through legal restrictions.
As a new decade has begun, this editorial reviews some of the biggest, brightest, and boldest happenings from the industry over the past 10 years.
December 18, 2019
The guidance describes procedures for obtaining an additional National Drug Code for prescription drugs imported into the United States.
FDA sent a warning letter to Dercher Enterprises, Inc., DBA Gordon Laboratories, for CGMP violations and adulterated drug products.
December 15, 2019
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
Warning letters tell the tale of missteps by drug companies and offer a path to compliance for quality teams that monitor these enforcement actions.