Quality Systems

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

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.

FDA Announces New Policy on Advisory Committee Members

Videos

As single use becomes more prevalent, end users are looking for more customization, and regulators are refining their rules, says Todd Andrews of CPC in an interview with Pharmaceutical Technology® Group.

INTERPHEX 2025: ‘Breaking Up the Octopus’ of Single-Use Systems

Feliza Mirasol is the science editor for 

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

FDA Issues Warning Letter to Aspen Biopharma Labs for API Manufacturing Deviations

Rivaroxaban, long known under the brand name Xarelto, is an anticoagulant, a classification that is among the most-prescribed medications in the United States.

FDA Approves First Generics of Rivaroxaban Tablets

The alterations are the result of an agency review of findings from a clinical trial, and data from required postmarket studies.

FDA Makes Class-Wide Labeling Changes to Testosterone Products

CHMP gave its opinion and a recommendation for marketing authorization to Fabhalta (iptacopan), an oral, Factor B inhibitor of the alternative complement pathway.

Novartis Treatment for C3G Gets Positive Opinion from EMA

More than 6000 rare diseases—those which affect fewer than one in 2000 people each—are acknowledged in the medical community, with 72% of them being genetic.

Rare Disease Day Celebrated on February 28

Treatments for autoimmune diseases, multiple cancers, and skin blistering have been recommended for marketing approval.

EMA Recommends Four Medicines for Approval in February

Cerebrotendinous xanthomatosis, or CTX, is a metabolic disorder caused by a gene mutation that results in a deficiency of an important enzyme in the ability of the human body to break down fats.

FDA Approves First Treatment for Rare Lipid Storage Disease Cerebrotendinous Xanthomatosis

Seladelpar, which is marketed in the US as Livdelzi, was recommended for an orphan drug designation by CHMP in December 2024.

Regulatory Oversight and Compliance