Physician's Weekly
JUNE 18, 2025
Cost-sharing interventions and patient education can help improve access to GLP-1 receptor agonists for patients with obesity, according to an abstract presented at the AACE Annual Meeting 2025. Other Persistent Barriers & Potential Solutions In another article not presented at the meeting, Stephanie W.
FDA Law
JANUARY 9, 2025
A foreign food manufacturer that refuses to permit entry of [FDA inspectors} to inspect such factory, warehouse, or other establishment can be subject to an import alert under section 807(b) of the FD&C Act. FD&C Act 501(j). But what exactly constitutes delaying, denying, limiting or refusing an FDA inspection?
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FDA Law
MAY 8, 2023
Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.
FDA Law
JUNE 28, 2021
Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000. The companion bill was already passed by the Minnesota Senate and has a presentment date of today, June 28, 2021.
FDA Law
DECEMBER 12, 2022
How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient. The approved devices already have patient‑directed labeling that FDA has approved. What is going on here?
CDOCS
JUNE 30, 2021
Next, following manufacturer’s instructions for use, CLEARFIL™ CERAMIC PRIMER PLUS (Kuraray Noritake) was applied to the intaglio of each restoration, followed by PANAVIA™ V5 Tooth Primer to each tooth prep, and lastly PANAVIA™ V5 Cement to the intaglio of each restoration prior to final seating.</span></p>
FDA Law
OCTOBER 14, 2024
The lowest risk category, which is not subject to any oversight by FDA, includes HCT/Ps removed from an individual that are implanted into the same individual during the “same surgical procedure.” FDA has a tiered, risk-based approach to regulating HCT/Ps, with three levels of oversight depending on the category of HCT/P.
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