Quality Systems

Leaders at CDER and CBER give update on organizational changes at FDA.

The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.

Anemia, experienced by most myelofibrosis patients, has caused over 30% of patients to discontinue their treatment.

Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference.

Iopofosine provides targeted delivery of idodine-131 directly to cancer cells.

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

Colorcon provides customers with Opadry complete film coating systems, which intends to help reduce complexity with delivering high-quality products and ingredients.

The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.

Advanced analytical tools generate more data in today’s labs than ever before.

Excipients should be treated equally when it comes to quality management, risk assessment, and testing.

FDA is anticipating how AI may advance manufacturing and improve supply chain security.

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

Modular facilities allow for a certain amount of flexibility and reconfiguration options.

A structured cleaning procedure is essential to ensure the effective cleaning of equipment.

The ACT EU initiative aims to develop the European Union further as a competitive centre for innovative clinical research.

There are many promising trials in the pipeline that may bring big news for major therapeutic areas.

Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.

The Centers for Medicare & Medicaid Services (CMS) has announced the first 10 drugs covered under Medicare Part D selected for negotiation.

Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) is approved as a first-line treatment for anemia in adults with lower-risk myelodysplastic syndromes.

The updated vaccine will be ready to ship following a positive European Commission review.

This is the first biosimilar to Tysabri, an injection for adults with multiple sclerosis.

Adam Smith, a House of Representatives member representing Washington's 9th congressional district, discusses the state of U.S. healthcare and pharma.

The patent grants Alterity 20 years of exclusivity over a new class of iron chaperone drug candidates.

FDA has approved a new mAb therapy from Regeneron Pharmaceuticals as well as a higher dose version of Eylea, the company’s eye disease therapeutic.