Quality/GMPs

Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.

Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.

That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.

Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.

GAO calls for more oversight of institutional review boards in clinical trials.

Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.

After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policy makers have added a “stick” to the process.

Biden outlined a host of priorities for improving health care and building the economy during State of the Union address.

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.