Quality Assurance/Quality Control

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

July 12, 2018

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

EMA Reviews Product from China Facility

July 05, 2018

The agency is reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

FDA Releases ANDA Submission Guidance

July 03, 2018

The agency published guidance on how the Generic Drug User Fee Amendments Reauthorization of 2017 applies to amendments to ANDAs and PASs.

Testing Foreign Particulate Matter in Inhaled Products

July 02, 2018

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates in inhaled drug products.

FDA Seeks to Revive Quality Metrics Initiative

July 02, 2018

The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.

Congress and FDA Take Action to Combat Opioid Crisis

July 02, 2018

Legislators look to widen access to medications for addiction treatment and overdose emergencies.

New Orbitrap ID-X Tribrid Mass Spectrometer Enhances Small-Molecule Characterization

July 02, 2018

Pharmaceutical Technology's In the Lab eNewsletter

Thermo Fisher Scientific’s mass spectrometer combines mass-analyzer technology with an intelligent data acquisition strategy.

Shimadzu’s New Q-TOF System Enhances Mass Spectrometry

July 02, 2018

Pharmaceutical Technology's In the Lab eNewsletter

The company’s new LCMS-9030 system is designed for high resolution and accurate mass detection.

Thermo Fisher’s Newest Mass Spectrometry Innovations Deliver Better Performance

July 02, 2018

Pharmaceutical Technology's In the Lab eNewsletter

The company unveiled its latest innovations to its mass spectrometry portfolio at ASMS in San Diego.

EDQM Annual Report Showcases 2017 Highlights

July 02, 2018

The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.