Quality/GMPs

A document signed by members of more than 400 companies and investment firms decries the decision made by a federal judge concerning mifepristone, a medication used in abortions.

Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides?

The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies.

FDA aims to address mounting criticisms of its accelerated approval pathway.

FDA has spurred investment to create and develop 600 therapies.

FDA has approved Evkeeza for young children with homozygous familial hypercholesterolemia.

Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.

Pierre Luzeau, CEO of Seqens, discusses Seqen's commitment to sustainability and how one can work toward it within their own company.

The Supreme Court heard oral arguments concerning the legitimacy of “genus clauses” in bio/pharma patents.

Narcan, from Emergent Solutions, will be the first naloxone product permitted for use without prescription by FDA.

A new Interagency Working Group for Bayh-Dole will review the government’s authority to revoke licenses for medical products.

27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation.

Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.

This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.

Quality quartets support an integrated and stable combination of commissioning and qualification and quality risk management processes.

FDA is seeking $7.2 billion to enhance food safety and advance medical product availability.

Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.

Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.

That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.