Regulatory

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.

How innovation growth has upped the pressure on China to compete globally, forcing upgrades in regulatory, quality, and standards.

How the nation’s rapidly changing regulatory climate is creating a new landscape for pharmaceutical service providers

Drug importing, advertising, rebates, and industry practices are on the table as legislators zero in on pharma pricing strategies.

New HHS proposed strategy to remove the current safe harbor protection from the federal Anti-Kickback Statute for rebates or discounts provided to Medicare Part D drug plans and certain state Medicaid programs.

The FDA proposes to use the RWE Program to guide generation of data in support of approval for new indications or to help support post-approval study requirements.

FDA restarted full operations on January 28 following Congressional agreement on a continuing resolution to fund government operations for three weeks. However, the situation will get much worse if Congress and the White House fail to negotiate a longer-term budget for 2019 by February 15.

It’s been a banner year in the new drug approval business: CDER approved 59 novel drugs and biologics in 2018, surpassing previous high marks and improving on recent gains, with additional new products approved by the CBER boosting the total.

CDER priorities for 2019 include opioids, quality, safety, and innovation.

As we pass the 6-month anniversary of theGeneral Data Protection Regulation's effective date, the number of organizations which boast 100% GDPR compliance has certainly increased. But life sciences companies are still grappling with implementation of the policy and procedure changes, writes Ashley Williams.

James Clark addresses one of the key questions data protection and compliance officers are asking following the implementation of the General Data Protection Regulation -"What role am I playing under the GDPR?"

Pharmaceutical regulatory divisions should use the same discipline, rigor and focus on the talent pipeline as they do the product pipeline, writes Karin Van Baelen.

The industry should take a twin-track approach to the potential threat of the Trump administration's proposed move to reference pricing, writes Todd Edgar.

Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages of important medicines and in the duration of supply problems. Jill Wechsler reports.

Regulators, prosecutors shifting enforcement focus from off-label promotion to messages that raise safety issues, mislead.

Efforts intensify to bring outlays more in line with global trends.

Healthcare was the deciding issue for more than 40 percent of voters in the mid-term elections. Despite disagreement on most of the issues, leaders of the two parties are open to challenging the status quo on drug costs and spending.