Regulatory Authority Actions

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.

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.

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.

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.

The European Commission has approved Cosentyx for the treatment of various childhood arthritic conditions.

The European Commission has approved Xenpozyme as the first treatment for ASMD.

The action plan will span over five years and will fulfill a requirement of the Accelerating Access to Critical Therapies for ALS Act.

Regulators wish to expand and clarify methods for obtaining information on medicines used by or needed for pregnant and lactating individuals through clinical trials and postapproval studies.

The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.

FDA is at a pivotal moment because of important gains in medical treatment based on science.

The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.

Measure tackles infant formula, cosmetics, diagnostics plus drug development and access.

The new draft guidance describes a standards recognition program for regenerative medicine therapies.

The draft ICH Q9(R1) document details the importance of quality risk management principles.

The European Commission has granted conditional marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for CARVYKTI (ciltacabtagene autoleucel), a cell therapy for treating multiple myeloma.

The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.

Roche has received approval from the European Commission for Lunsumio (mosunetuzumab), the first CD20xCD3 T-cell engaging bispecific antibody for treating follicular lymphoma.

FDA has approved GSK’s vaccine for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.

Manufacturers are aligning with pharmacists and providers to blame high drug costs and limited patient access on pharmacy benefit managers.