Regulatory Watch

Jul 02, 2018
Pharmaceutical Technology
EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.
Jul 02, 2018
Pharmaceutical Technology
FDA seeks more efficient testing to spur development of less costly biotech therapies.
Jul 02, 2018
Pharmaceutical Technology
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
Jun 02, 2018
Pharmaceutical Technology
FDA and Congress seek to limit the production and distribution of pain medicines.
Jun 01, 2018
Pharmaceutical Technology
Pharmaceutical companies and their contractors are reorganizing their manufacturing lines and logistics to ensure compliance with the serialization requirements, but many SMEs are struggling to meet the deadline.
May 02, 2018
Pharmaceutical Technology
FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
Apr 02, 2018
Pharmaceutical Technology
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
Mar 02, 2018
Pharmaceutical Technology
Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.
Feb 02, 2018
Pharmaceutical Technology
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
Jan 02, 2018
Pharmaceutical Technology
Policy makers look to boost generic drugs, curb opioid abuse, and maintain incentives for innovation.
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