Quality/GMPs

A realignment of the Office of Regulatory Affairs would create a focus on “critical activities” for ensuring the safety of foods and other regulated products, including drugs, biologics, and medical devices.

Variability instills consistency in advanced therapy medicinal products.

A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.

The restraint to not target solely the major disease groups has provided good proportion and balance for our industry.

FDA will restart in-person, face-to-face meetings with industry sponsors beginning Feb. 13, 2023, after a shift to all-virtual meetings during the pandemic.

Big data is a natural for pharmaceutical industry players that have not already embraced it.

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.

The Vault Quality Suite will help Adare simplify its quality operations across its sites in the United States, France, and Italy.

The company was awarded the Terra Carta Seal in recognition of its commitment to creating a sustainable future.

Advanced LC technologies can streamline the review process for LC equipment maintenance.

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.