Regulatory

Advice for developers in steering gene therapies from concept to trials to hopeful approval in what is an uniquely complex path.

HHS, FDA back Trump back cheaper foreign drugs to cut pharma costs. Jill Wechsler reports.

Agency focused on advancing testing and production methods, seeking input from other regions on common approaches.

Efforts in motion for cross-border sharing, but barriers are many

In their latest article summarizing efforts to put each of the “American Patients First” blueprint's four strategies into action, Rick Kelly and Nisha Desai focus on the Lowering Out of Pocket (OOP) Costs strategy.

How R&D organizations can leverage FDA’s final guidance on pre-approval information exchange (PIE) to engage with payers prior to approval and launch.

What to make of the simmering public and political angst

New guidances open the door to interchangeables and less costly insulin.

In the third in a series of articles summarizing efforts to put each of the “American Patients First” blueprint's four strategies into action, Rick Kelly and Nisha Desai focus on “Incentivizing Lower List Prices.”

R&D organizations can leverage FDA’s final guidance on pre-approval information exchange, otherwise known as PIE, to engage with payers prior to regulatory approval and commercial launch.

A provision in a Senate health reform bill has reignited debate over the whether biological products should have to meet product quality standards established by the U.S. Pharmacopeia.

Congress is weighing in on drug pricing with a range of measures that differ in style and substance.

Cell and gene therapies in crosshairs of pricing focus, prompting stepped-up proposals on ways to finance these products.

Sabina Heinz and Elizabeth Baynton look at how the continued absence of approved products affecting the management of NASH patients.

In the first in a series of articles addressing each of the American Patients First blueprint 's four strategies, Rick Kelly and Nisha Desai focus on “Increasing Competition”.

Jill Wechsler looks at the proposed new FDA rules to beef up regulatory resources and promote digital technologies to support the development and marketing of safe and innovative over-the-counter therapies.

FDA is examining and updating its programs for overseeing global operations and international affairs.

New leadership faces a host of complex initiatives to promote innovation and protect public health.

Elvis Paćelat outlines some lessons from big pharma as medical device manufacturers succumb to new reporting obligations.

New FDA leader Ned Sharpless will seek further solutions to the opioid crisis and work to reduce cigarette use in adults and kids.

A new CDER “knowledge management” approach will see companies submit applications that can be transmitted to experts from multiple disciplines able to assess applications for new drugs and biologics in a timely and efficient manner.

Follow-on product naming, messaging challenge FDA, industry.

Europe slow to action on emerging technologies, but the complex issues clouding EHRs and gene editing, for example, offer pause.

Executives from DIA, Ranjini Prithviraj and Sudip Parikh discuss documents the FDA released that further detail the agency’s implementation plan for its Software Precertification Pilot Program.

Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.

The digitization of healthcare is paving the way to accelerate drug development in the industry, and the FDA is doing its best to support industry.

Wide-ranging probes to target marketing, pricing, and access.

Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.

Dr. Lingshi Tan, a director at DIA, and chairman and CEO of Shanghai-based CRO dMed Company Limited, which he founded after establishing R&D operations for Pfizer in China, discusses the nation's regulatory evolution and opportunities for its government to strengthen collaborations with FDA and other leading global agencies.

FDA came away with the largest boost in its annual budget in a decade as part of the final spending package approved by Congress last week.