Quality/GMPs

Eisai’s Alzheimer’s treatment, Leqembi (lecanemab-irmb), received approval from FDA via the Accelerated Approval pathway.

The agency revised a regulation to enable pharmacies to dispense mifepristone directly to individuals with a prescription.

Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.

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

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

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

FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US.

FDA struggles to track shortages caused by a rise in demand.

The complete online database of ACS Reagent Chemicals is now available.

Manufacturing biopharmaceuticals in an aging facility may create quality issues such as equipment breakdown and contamination risks.

The design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.

Digitalization of bioprocessing is slowly bringing benefits to the biopharma industry.

Health crises, political tension, and budget concerns were major challenges.

Etihad Cargo is one of the only airlines to hold IATA CEIV Pharma certification globally.

CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.

Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session.

The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.

New medications show exciting outcomes for weight loss.

Industry experts discuss best practices for certificates of analysis.

A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.

FDA keeps its user fees but fails to gain important reforms.

Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.

Next year's "FDA Voices" series will cover core topics FDA staff are prioritizing.