Jill Wechsler

A recent report released by an FDA task force highlights the financial, manufacturing, and policy issues underlying the drug shortages of important prescription medicines in the United States.

Falsified documents and manipulated test results prompt warnings and investigations.

After months of planning and explaining, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), 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.

The multitude of health reform measures emerging on Capitol Hill has accelerated lobbying action across the board, along with campaign donations to candidates from all sides.

Industry and regulators seek global system that reduces regional differences.

New tools and policies aim to support more complex manufacturing processes.

FDA, Health and Human Services, and the Trump Administration back cheaper foreign drugs to cut pharma costs.

New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.

The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.

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

CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight.

FDA is supporting the development and marketing of OTC therapies, including CBD products, by proposing new rules and an expanded review office and promoting digital technologies.

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

New agency leadership is pressed to promote innovation while addressing safety and quality issues.

CDER Director Janet Woodcock is finalizing this more streamlined approach process for evaluating new drugs to handle the surge in drug application submissions.

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

FDA is moving to shift industry away from step-wise batch production.

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.

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

FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.

The agency clarified the process for development programs for regenerative medicine therapies.

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

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.

Policies emphasize the importance of ensuring data integrity in the United States and abroad.

FDA staffers will be hard-pressed to process and review the wave of new drug application submissions in pre-established timeframes for action.

Industry investment and regulatory support combined to move many important new medicines to market.

FDA plans to support initiatives to ensure that all medicines are safe, effective, and of high quality.

Despite ongoing efforts to address drug shortages, FDA now sees a rise in active shortages and in the duration of supply problems.