Quality Systems

FDA Resumes In-Person Meetings with Industry … Sort Of

January 31, 2023

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.

FDA Seeks to Simplify COVID-19 Vaccination Program

January 30, 2023

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

FDA Rejects Accelerated Approval for Lilly’s Alzheimer’s Drug

January 23, 2023

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.

Adare Pharma Solutions Coordinating Quality with Veeva Vault Quality Suite

January 13, 2023

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

Spectrum Laboratory Products Issues Recall of Epinephrine USP Bulk API Due to Discoloration

January 11, 2023

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person.

Samsung Biologics Receives the Terra Carta Seal

January 11, 2023

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

FDA Grants Accelerated Approval for Eisai Alzheimer’s Disease Treatment

January 10, 2023

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

FDA Policy Change Heightens Debate Over Medicated Abortion

January 05, 2023

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

Opening Up Opportunities in 2023

January 03, 2023

Bio/pharma has evolved and adapted to a variety of challenges in 2022, but what might be on the cards for the industry in 2023?

Crossing the Same River Multiple Times

January 03, 2023

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