Quality Systems

Articles

Laboratoire HRA Pharma norgestrel is the first daily tablet for nonprescription use to prevent pregnancy.

FDA Approves First Nonprescription Daily Oral Contraceptive 

Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.

FDA Converts Eisai Alzheimer’s Treatment to Traditional Approval

The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.

EMA Reviews GLP-1 Receptor Agonists for Self-Harm Risk

EMA looks to focus on mRNA vaccines because their classification depends on the target and/or whether they are obtained chemically or biologically. 

EMA Aims to Develop Guideline for mRNA Vaccines

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

FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition

Large Clinical Trial Supports Alzheimer Drug Full Approval

EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.

Europe Phases Out COVID-19 Flexible Regulations

Full Marketing Authorization has been granted for Novavax’s COVID-19 vaccine by the European Commission.

COVID-19 Vaccine, Nuvaxovid, Gains EU Approval

Feliza Mirasol is the science editor for 

FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.

FDA Approves BioMarin’s Roctavian, the First Gene Therapy for Treating Severe Hemophilia A

Ghada Haddad, PhD, is executive director, Global Quality Transformation Global Quality Shared Services & Regulatory Intelligence Merck & Co.

Darshana Patel is an associate director in Global Quality at Merck & Co., Inc.

The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.

Navigating the Formality Spectrum in ICH Q9(R1)

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

Regulatory Oversight and Compliance