Regulatory Beat

Policy makers look to boost generic drugs, curb opioid abuse, and maintain incentives for innovation.

New gene therapies and combination products require innovative regulatory approaches.

Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.

Reliable, high-quality products require innovative analytics and production.

FDA seeks to focus on problematic facilities and inform firms quickly about site problems.

Industry and FDA face new fee structures and new challenges in implementing fee initiatives.

FDA works with industry on strategies for assuring high-quality regenerative medicines.

FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 

CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.

Approval of breakthrough therapies requires expedited quality assessment.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

Industry fears limited benefits as FDA readies voluntary data tracking program.

Manufacturers face uncertainty over imports, regulatory policies, and field inspections.

User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.

How involved should HTA bodies be in assessing cost effectiveness and reimbursements?

FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.

Republican control of Washington promises overhaul of healthcare and medical product regulation.

Efforts to accelerate drug development will alter fee structure and require ready production sites.

Manufacturers and regulatory authorities seek coordinated lifecycle management policies.

Regulators and manufacturers address economic and ethical issues for scarce medicines.

Agency guidance and industry standards aim to reduce lapses and improve quality operations.

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

Global outbreaks energize vaccine R&D and drive production modernization.

The campaign against opioid abuse opens door to more innovative therapies.

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.

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

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

FDA confirmed quality focus while Congress moved to bolster biomedical innovation.

New program emphasizes quality, risk, and global collaboration.