Jill Wechsler, Pharm Exec’s Washington Correspondent

Lapse spotlights wider actions to ensure data accuracy.

The Center for Drug Evaluation and Research has finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs.

Time is running out on Ned Sharpless’ term as FDA acting commissioner, generating much talk as the administration shows interest in naming a new head for the agency.

Market consolidation limits sales, while legal challenges offset regulatory gains.

As part of the legislation expanding the federal Open Payments program, drug and medical device manufacturers will have to report payments and other “transfers of value” to a broader range of health professionals.

Jill Wechsler casts her eye over the multitude of health reform measures emerging on Capitol Hill.

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.

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

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.

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.

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.

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

The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.

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

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

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.

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

New HHS proposal would 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.

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.

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.

To further streamline product development and facilitate post market safety surveillance, the agency has developed a new Framework for Real-World Evidence that spells out opportunities and concerns in advancing these approaches.