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November 02, 2019
It is good industry practice to clarify the precise remit for each of the reviewers of a controlled document, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
Unforeseen challenges can be avoided in technology transfer by evaluating the variety of processes involved.
October 28, 2019
The company is recalling Alprazolam Tablets, USP C-IV 0.5 mg because of potential presence of foreign substance.
October 24, 2019
Dr. Reddy’s, Sanofi, and Perrigo Company issued voluntary recalls of ranitidine in October 2019 because of N-Nitrosodimethylamine contamination.
October 21, 2019
The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process.
The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.
October 17, 2019
Sarah Hardison, head of Regulatory and Pharmacovigilance Solutions, Clarivate Analytics, will regulatory tackle trends in her presentation on the World of Pharma Podium during the second day of CPhI Worldwide.
A recently published European Medicines Agency (EMA) report has demonstrated that there are continued efforts being made across Europe to reduce the amount of antibiotics used in animals.
October 11, 2019
Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products due to a lack of assurance of sterility.
The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.