Regulatory Authority Actions

Kovaltry is an unmodified, full-length recombinant factor VII product used to treat hemophilia A in adults and children.

The European Medicines Board elects Christa Wirthumer-Hoche as chair of their Management Board.

Both agencies warn of increased rates of serious adverse events, including death, during clinical trials of Zydelig (idelalisib).

Doctors and oncologists agree with pharma companies in opposing the latest proposal from the CMS to revise how it pays for drugs administered in doctors’ offices.

The company recalls one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of glass particulate in one vial.

The group argues that the so-called “incentives” for physicians to prescribe more costly medications are essentially non-existent following a handful of prior cuts to Medicare Part B reimbursement.

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.

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

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.

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

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

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