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Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). Under the Administrative Procedure Act, FDA is obligated to address major substantive issues when – and not so much if – it publishes a final rule.
The Food and Drug Administration’s (FDA) draft guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials , recommends sponsors develop and submit a race and ethnicity diversity plan early in clinical development. Community-led.
Comment topics suggested by DEA include the following: Whether the rule should limit the issuance of prescriptions for controlled medications to FDA-approved indications contained in the labeling for those medications. The only schedule III-V narcotic drug that is currently approved by the FDA for OUD treatment is buprenorphine.
The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. The US FDA monitors quality, and Kopcha traced changes in regulation of quality over the years. FDA Activities in Support of Quality. Tue, 11/01/2022 - 06:49.
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”
Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. Join our next Awesome Webinar Series with guest legal guru JD from Real Value Rx to answer any questions you have about the DSCSA delay. The DSCSA Adventure continues.
As acknowledged in the Strategic Priorities document, certain demographic groups may have limited access to necessary treatments and diagnostics. FDA defines a Home Use Device as “a medical device intended for users in any environment outside of a professional healthcare facility. We previously blogged on the draft guidance here.
For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,
In the years leading up to 2022, numerous publications were issued; networking events, webinars, and conferences were held; and regulatory panel discussions with regulators performed. Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance? and management communication strategy.
By Ritte van Laack As we previously reported in 2022, FDA published a proposed rule defining the nutrient content claim healthy. FDA received more than 400 comments, resulting in a final rule published on December 27, 2024, covering more than 100 pages. The final rule maintains the concept of the proposed rule.
Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R. User Interface Software Description Section VI.B
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