Quality/GMPs

Democrats approve curbs for Medicare plans, but not for commercial drug coverage.

Better clinical data are needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

FDA’s hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations.

A strong digital backbone is foundational in driving innovation.

The European Commission has granted marketing authorization to Upstaza (eladocagene exuparvovec) for treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.

FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about biologics license applications.

How can we fix the quality manufacturing issues that come with product shortages?

Scrutiny of accelerated approvals has generated a range of reform proposals to accelerate the conduct of confirmatory studies.

The agency’s human medicines committee recommended drugs to treat breast cancer, lupus nephritis, type 2 diabetes and more.

A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.

Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.

Health Canada has authorized Moderna’s COVID-19 vaccine for use in young children aged six months to five years.

US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.

FDA has granted an Emergency Use Authorization to Novavax’s COVID-19 vaccine.

The European Medicines Agency guidance highlights key principles and examples of good practices to prevent and manage shortages of human medicines.

Application for OTC contraceptive highlights efforts to broaden access to medicines.

Some states look to block access to approved drugs.

LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.

An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel.

The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.

By understanding potential material change, the impact on patient safety can be understood and mitigated.

Improved real-time visibility during all segments of handling, transportation, and delivery is keeping costs low and reliability high while helping time- and temperature-sensitive biopharmaceuticals to go the distance without incident.

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.