Category: Regulatory/FDA

Regulatory/FDA

Regulatory/FDA

CDER, CBER Approve Total of 60 New Products in 2021, Despite Challenges

CDER, CBER Approve Total of 60 New Products in 2021, Despite Challenges

Jan. 4, 2022 – 2021 was a year of many healthcare challenges, but against this backdrop the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) approved 50 novel drugs and its Center for Biologics Evaluation and Research (CBER) approved 10 biological license applications (BLAs) (plus three source plasma products). CDER nearly […]

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Regulatory/FDA

CDER Steps in to Issue Warning Letters for Vaping Products Deemed Drugs

CDER Steps in to Issue Warning Letters for Vaping Products Deemed Drugs

Dec. 13, 2021 – Recent FDA Warning Letters calling out promotional claims made about vaping products are interesting in that they were issued not by the agency’s Center for Tobacco Products, but by the Center for Drug Evaluation and Research (CDER). “Although the FDA has been criticized for missing deadlines on approving or rejecting various […]

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Regulatory/FDA

FDA Reportedly Preparing Guidelines for Omicron-targeted Vaccine Studies

FDA Reportedly Preparing Guidelines for Omicron-targeted Vaccine Studies

Dec. 6, 2021 – As the seemingly fast-spreading COVID-19 omicron variant begins to show up in the United States, the Food and Drug Administration (FDA) is taking measures now to meet any potential need for new diagnostics, vaccines and therapeutics to combat the next phase of the pandemic. On Dec. 2, President Joe Biden announced […]

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Regulatory/FDA

OPDP Experimental Study to Examine Targeted Mechanism of Action Claims

OPDP Experimental Study to Examine Targeted Mechanism of Action Claims

Nov. 8, 2021 – Whether consumers and healthcare professionals (HCPs) are influenced by “targeted mechanism of action (MoA)” presentations in promotional materials for drugs is the subject of a proposed study by FDA’s Office of Prescription Drug Promotion (OPDP) research division. Public comments on the information collection activities associated with this research proposal are due […]

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Regulatory/FDA

FDA Draft Guidance for Real-world Data: Documentation of Data Approach Is Key

FDA Draft Guidance for Real-world Data: Documentation of Data Approach Is Key

Oct. 25, 2021 –  Translating real-world data (RWD) into a standard format that the Food and Drug Administration (FDA) can process, review and archive will pose challenges that are best met with detailed documentation of a sponsor’s data approach, according to the agency’s draft guidance on data standards for drug and biological products submissions containing […]

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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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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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