Quality Systems

Sean Milmo is a freelance writer based in Essex, UK.

Articles

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.

Collaboration on GMP Inspections Has Been Successful but Challenges Exist

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA and Congress seek to limit the production and distribution of pain medicines.

Manufacturers Under Pressure to Curb Opioid Use and Abuse

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.  

Meeting the EU Serialization Deadline

FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.

Gottlieb Tackles Tough Issues in First Year at FDA

Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.


Modern Manufacturing Key to More Effective Vaccines

Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.

FDA Heightens Drive for Transparency

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.


Opportunities and Obstacles for Generic Drugs

Policy makers look to boost generic drugs, curb opioid abuse, and maintain incentives for innovation.

Drug Pricing and Quality Are Top Issues for 2018

New gene therapies and combination products require innovative regulatory approaches. 

Transformative Medicines Challenge FDA and Manufacturers

FDA seeks to focus on problematic facilities and inform firms quickly about site problems.

Regulatory Watch