OR WAIT null SECS
September 10, 2013
McNeil Consumer Healthcare Division of McNeil-PPC announced a voluntary recall of three lots of Motrin Infants? Drops after 1 mm plastic particles were identified in a different product lot during manufacturing.
September 09, 2013
Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.
FDA inspections reveal possible inaccurate sterility testing.
September 02, 2013
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
August 28, 2013
FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.
August 27, 2013
Dr. Reddy's initiates voluntary recall of ranitidine due to microbial contamination.
August 14, 2013
CDER withdraws some outdated guidance documents and makes plans to finalize others.
August 07, 2013
The guidance describes a risk-based approach to monitoring of clinical trials.
July 12, 2013
The precautionary recall follows manufacturing deficiencies identified at the site in India.
July 02, 2013
Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.