Quality/GMPs

Concerns that physicians are not prescribing the most cost-effective medications available have prompted the Centers for Medicare and Medicaid Services to propose a set of new potential reimbursement schemes for Part B drugs in Medicare. CMS says the new proposed rule will test new payment approaches to reward good patient outcomes and will inject value into the system.

Sagent Pharmaceuticals issues a nationwide recall of Fluconazole injection, USP, due to out of specification impurity results.

The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.

Policy makers debate strategies for promoting access to less costly medicines.

Data integrity is a widespread, global problem that must be addressed.

Real-time GPS technology, better IT connections, and more conservative, controlled shipping temperatures are improving the shipment of sensitive pharmaceuticals.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.

The program is intended to provide support to ongoing efforts in rare disease product development.

The agency has revised its good pharmacovigilance practices guide on risk management systems.

The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.

The company issues a voluntary recall of a lot of 0.9% sodium chloride solution due to particulate matter.

The directorate is looking for experts to join the European Pharmacopoeia network.

Recipharm plans to invest €40 million in the project as a result of EMA decision to make serialization of licensed drug products a legal requirement by 2019.

The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.

The agency is continuing CDER’s Regulatory Project Management Site Tours and Regulatory Interaction Program.

FDA cracks down on makers of products extracted from Cannabis and says the products cannot be considered dietary supplements.

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.

On Feb. 9, 2016, an FDA Arthritis Advisory Committee will meet to discuss a biologics license application (BLA) for CT-P13 (Remsima), a proposed biosimilar to Janssen Biotech's Remicade (infliximab), by South Korea’s Celltrion in partnership with Pfizer. The BLA was submitted via the abbreviated 351(k) pathway and seeks to cover all of the eight indications that are approved for Remicade.

The agency prepares a plan to implement new packaging safety features.

FDA granted Immunomedics breakthrough therapy designation for the company’s investigational antibody drug conjugate for treatment of triple negative breast cancer.

FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.

Can the feds negotiate Medicare Part D prices?

CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.

FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.

Understanding of the risks associated with FMEA is crucial in lot release testing.

The recognition that microbial artifacts are capable of modulating the mammalian immune system is an emerging view of biologic drug contamination control testing.

FDA and industry seek a more consistent, flexible CMC review process for breakthrough therapies.

Amgen announces FDA will review the company’s BLA for ABP 501.

The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.