Category: Regulatory/FDA

Regulatory/FDA

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Comment Now on FDA Draft Guidance on Use of EHR, Claims Data as RWD

Comment Now on FDA Draft Guidance on Use of EHR, Claims Data as RWD

Oct. 4, 2021 – As part of its real-world evidence (RWE) program, the Food and Drug Administration last week issued a draft guidance to provide sponsors, researchers and other stakeholders with the agency’s current thinking about the use of electronic health records (EHRs) or medical claims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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Regulatory/FDA

OPDP Enforcement Letter to Eton Pharmaceuticals Cites Omission of Risk Info in Sponsored Links

OPDP Enforcement Letter to Eton Pharmaceuticals Cites Omission of Risk Info in Sponsored Links

Aug. 30, 2021 – In an Aug. 9 Untitled Letter, FDA’s Office of Prescription Drug Promotion (OPDP) cited Eton Pharmaceuticals Inc. for presenting benefit information in sponsored links for Alkindi® Sprinkle (hydrocortisone) oral granules without including any risk information about the product, which “is used in a vulnerable pediatric population” and may cause serious adverse […]

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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

OPDP To Study Impact of Exhibit Booth Materials, Medical Conference Conversations on HCPs

OPDP To Study Impact of Exhibit Booth Materials, Medical Conference Conversations on HCPs

July 29, 2021 – Because medical conference exhibit booths provide opportunities for pharmaceutical companies to market their products to large numbers of healthcare professionals (HCPs), the FDA’s Office of Prescription Drug Promotion (OPDP) is planning to study how exhibit materials and conversations between booth reps and HCPs affect HCPs’ perception of promoted drugs. OPDP cites […]

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Regulatory/FDA

Amgen Gets OPDP Untitled Letter for Claims about Neulasta Onpro vs. PFS Delivery

Amgen Gets OPDP Untitled Letter for Claims about Neulasta Onpro vs. PFS Delivery

July 26, 2021 – The FDA’s Office of Prescription Drug Promotion (OPDP) cited Amgen for making misleading claims that the delivery of its product Neulasta® through the Onpro® on-body injector is more effective than delivery through the pre-filled syringe (PFS) or is more effective than FDA-licensed biosimilars, which are only available through PFS. OPDP takes […]

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Regulatory/FDA

CDER Approves 27 Novel Drugs in First Half of 2021

CDER Approves 27 Novel Drugs in First Half of 2021

July 12, 2021 – The COVID-19 pandemic did not slow down the drug approval process for the FDA’s Center for Drug Evaluation and Research (CDER) in 2020 – a year that saw CDER approve the second-highest number of new molecular entities (NMEs) – and that pace seems to be holding steady in 2021, with CDER […]

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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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