Quality Systems

Articles

The 100% tariff on imported drugs will pressure pharma companies to build manufacturing sites in the US or face significant costs.

How 100% Pharmaceutical Tariffs Will Impact Domestic Manufacturing and Supply Chains 

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

The FDA draft guidance "Considerations for Complying with 21 CFR 211.110" raises points to consider regarding drug products made using advanced manufacturing, batch uniformity, drug product integrity, and how manufacturers can incorporate process models into control strategies.

Stakeholders React to FDA's Push for Quality, Integrity, and Uniformity

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

Opposing Reactions as RFK Jr. Removes Thimerosal from Flu Vaccines

 has more than 20 years of experience in the pharmaceutical industry. She has built her career in the areas of computer system validation, IT quality, and computer systems quality assurance. And while her current role focuses on data integrity, DI has been an important driving force throughout her entire career. She is an audit trail review subject matter expert, a leader in process improvement, and happily challenges the status quo.

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.

A Novel, Enhanced, and Sustainable Approach to Audit Trail Review

The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.

FDA Posts Slate of Seven Warning Letters Following Company Inspections

A Phase III trial demonstrated mNEXSPIKE’s non-inferior efficacy compared with Moderna’s original COVID vaccine, Spikevax.

FDA Approves New Moderna COVID-19 Vaccine mNEXSPIKE

The concerns of industry experts expressed at INTERPHEX in April 2025 are still pertinent in an uncertain global political climate.

Geopolitical Shifts Change Nature of Pharma Partnerships

Bempikibart (ADX-914) is a human anti-IL-7Rα antibody that blocks the IL-7 and TSLP pathways, which have been implicated in driving T cell-mediated pathological processes in autoimmune diseases.

FDA Grants Fast Track Designation to Q32 Bio Treatment for Alopecia Areata

The company said that Vyvgart (efgartigimod alfa) is the first novel mechanism of action for CIDP treatment in more than 30 years.

CHMP Recommends argenx Treatment for Chronic Inflammatory Demyelinating Polyneuropathy

The policy announced by Commissioner Martin A. Makary, MD, will not preclude employees of regulated companies from presenting their views to committees, and rare exceptions will be allowed.

Regulatory Oversight and Compliance