Tag: FDA

FDA

Washington Focus

Pressure Mounting for FDA Commissioner Among Reports that Califf Will Be Biden’s Choice

Pressure Mounting for FDA Commissioner Among Reports that Califf Will Be Biden’s Choice

Oct. 21, 2021—Nine months into President Joe Biden’s administration, he has still not nominated a candidate to take the helm at the Food and Drug Administration (FDA). Amid the COVID-19 pandemic and other pressing healthcare issues, the pressure is rising for a permanent FDA commissioner, but many of the frequently-named frontrunners for the position appear […]

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Regulatory/FDA

FDA Issues BsUFA Commitment Letter, to Hold Public Meeting Nov. 2

FDA Issues BsUFA Commitment Letter, to Hold Public Meeting Nov. 2

Oct. 11, 2021 – The Food and Drug Administration (FDA) will hold a virtual public meeting Nov. 2 to discuss the proposed changes it would like to make during the reauthorization process for the Biosimilar User Fee Act for fiscal years 2023 through 2027 (BsUFA III). The current legislation, BsUFA II, will expire in September […]

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Regulatory/FDA

Comment Now on FDA Draft Guidance on Use of EHR, Claims Data as RWD

Comment Now on FDA Draft Guidance on Use of EHR, Claims Data as RWD

Oct. 4, 2021 – As part of its real-world evidence (RWE) program, the Food and Drug Administration last week issued a draft guidance to provide sponsors, researchers and other stakeholders with the agency’s current thinking about the use of electronic health records (EHRs) or medical claims data in clinical studies “to support a regulatory decision […]

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Regulatory/FDA

FDA, HRA Starting to Address Trial Investigator Result Reporting Lapses

FDA, HRA Starting to Address Trial Investigator Result Reporting Lapses

Sept. 27, 2021 – In the midst of public scrutiny regarding clinical trial transparency, the Food and Drug Administration (FDA) and the United Kingdom’s Health Research Agency (HRA) recently took actions that may indicate their increased willingness to more closely monitor clinical investigators who do not report trial results in a timely manner. “Pharma, researchers, […]

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Regulatory/FDA

BMJ Study: Accelerated Approval Drugs Retain Status Despite Lack of Benefit

BMJ Study: Accelerated Approval Drugs Retain Status Despite Lack of Benefit

Sept. 20, 2021 – Six out of 18 cancer drugs that initially received accelerated approval from the FDA have indications that remain on the labeling and continue to be recommended in clinical guidelines despite post-approval trials demonstrating no improvement in the primary endpoint, according to a retrospective observational study published Sept. 9 by BMJ. “The […]

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Legislative

FDA Shares Drug Review Priorities, Sets Date for Public Meeting

FDA Shares Drug Review Priorities, Sets Date for Public Meeting

Sept. 10, 2021 – The Food and Drug Administration (FDA) recently issued a commitment letter regarding the next iteration of the Prescription Drug User Fee Act (PDUFA VII) that spells out its review timeframes, performance goals and modernization priorities for fiscal years (FYs) 2023-2027. Among these priorities are enhancements related to expediting drug development, expanding decision […]

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Regulatory/FDA

FDA Accepting Comment on Burden of Drug Advertising, HCEI Communications Disclosures

FDA Accepting Comment on Burden of Drug Advertising, HCEI Communications Disclosures

Aug. 10, 2021 – The FDA is finalizing the burden estimates of complying with statutory requirements and guidance documents it previously issued on prescription drug advertising and the information drug companies communicate to payers and formulary committees and will accept comments on these estimates until Aug. 23. According a notice published in the July 23 […]

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Regulatory/FDA

FDA at Turning Point: Kate Rawson Explains

FDA at Turning Point: Kate Rawson Explains

June 11, 2021 – The Food and Drug Administration (FDA) “is really central, not only to product approvals, but to what [medical product companies] can say in terms of marketing,” according to Prevision Policy Senior Editor Kate Rawson. Rawson, who spoke June 4 at a Coalition for Healthcare Communication (CHC) webinar, “What’s Ahead for the […]

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Regulatory/FDA

Follow-up on Accelerated Drug Approvals Is Subject of FDA Advisory Panel

Follow-up on Accelerated Drug Approvals Is Subject of FDA Advisory Panel

May 6, 2021 – The outcome of a recent Advisory Committee meeting convened to review the uses of certain cancer drugs that were approved under the Food and Drug Administration’s (FDA’s) accelerated approval process sheds light on the potential pitfalls of the process after the approvals are granted. The FDA Oncologic Drugs Advisory Committee voted […]

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Washington Focus

Register Now: CHC Webinars Tackle Data Privacy Issues and the Future of the FDA

Register Now: CHC Webinars Tackle Data Privacy Issues and the Future of the FDA

April 26, 2021 – What happens in Washington doesn’t stay in Washington, and upcoming webinars will examine two of the areas most critical to healthcare marketing and communications: the use of personal data and protecting privacy, and what’s ahead for the FDA under new leadership. Registration is now open here for the two webinar programs, […]

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