Remove 2022 Remove Documentation Remove Labelling
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Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?

The FDA Law Blog

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

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It’s the Law Now –Cybersecurity Information in Premarket Submissions

The FDA Law Blog

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Through a recent (and very short) Guidance document, FDA indicated that, starting on October 1, 2023, FDA may base “refuse to accept” (RTA) decisions on the information required by section 524B. Loose Ends IDEs.

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10 foods high in vitamin D

The Checkup by Singlecare

Department of Agriculture (USDA) requires it to be labeled “farmed” or” wild-caught.” Check the nutrition facts label to find the amount of vitamin D and other nutrients contained in individual products. The nutritional fact label will identify the recommended daily value of vitamin D suggested for the average adult.

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Transition Plans for Covid-19 Products are Amongst CDRH FY2023 Priorities

The FDA Law Blog

On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ). These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023. The 1993 guidance documents largely pertain to 510(k) submissions for various device types (e.g.,

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Is Mounjaro covered by Medicaid?

The Checkup by Singlecare

Mounjaro (tirzepatide) is an injectable medication prescribed for Type 2 diabetes mellitus, which some doctors may prescribe off-label for weight loss. In 2022—the year Mounjaro hit the market—Medicaid dispersed nearly $30 million to help beneficiaries pay for it, according to KFF data. per 30-day supply (a pack of four pens).

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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

The FDA Law Blog

a) , and related guidance documents (e.g., The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA). FDA recommends manufacturers submit each modification, associated labeling changes and specific performance evaluation in the Modification Protocol (MP).

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