Topic

Articles

Experts weigh in on trends in the biotechnology market, psychedelics, and India.

Predicting Pharma’s Future

FDA sent a variety of warning letters to drug manufacturers at the end of 2022 highlighting myriad CGMP and quality control violations.

Write it Down, Investigate, and Control

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

In light of increasingly stringent sustainability requirements, bio/pharma companies need to make sure they formulate effective ESG strategies.

Setting Goals for Sustainability

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

Politics and drug shortages will continue to impact FDA and drug manufacturers in 2023.

A Rocky Road Ahead for FDA and Industry 

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Does the new regulatory framework have the potential to incentivise R&D investment in rare diseases?

Revision of the Orphan Medicines Regulation

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

A CCS provides significant benefits to the industry and helps with holistically understanding contamination controls, says Siegfried Schmitt, vice president, Technical at Parexel. 

Creating a Contamination Control Strategy

Additionally, 89 human medicines have been recommended for approval by the EMA, and the organization also analyzed a new vaccine against dengue and two diabetes treatments that address important public health issues outside the EU.

EMA Executive Director Sends Message of Promoting Stronger Public Presence for Safety, Efficacy of Medicines

In terms of extensions, the committee recommended Adcirca, Dupixent, Edistride, Enhertu, Fintepla, Forxiga, Hemlibra, Imfinzi (including two new indications), Kerendia, Spikevax and Triumeq.

EMA Recommends Five Medicines for Approval

The Consolidated Appropriations Act for 2023 provides FDA with a $6.6 billion total budget.

Massive Government Spending Bill Tackles Key FDA and Research Issues

The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy current good manufacturing practice (CGMP) requirements. 

Quality Systems