OR WAIT null SECS
September 01, 2016
FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.
August 29, 2016
The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.
The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.
August 17, 2016
The Chinese facility was cited for data integrity violations.
August 16, 2016
The agency publishes guidance on the appropriate classification of co-crystal solid-state forms.
August 15, 2016
The agency has adopted guidelines on the pharmacovigilance of biological drugs.
August 11, 2016
NICE recommends secukinumab for the treatment of patients with ankylosing spondylitis.
The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.
August 10, 2016
FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.
August 02, 2016
Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.