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Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.
Despite a high prevalence of childhood and youth-aged obesity, the use of medications for treating obesity is persistently low among children and young adults (YA), according to an abstract presented at the American Diabetes Association’s 85th Scientific Sessions, held in Chicago, Illinois, from June 20-23, 2025. Accessed June 25, 2025.
5–8 Highlighting the need for evidence-based formulations A case report by Morris et al describes a serious adverse event involving the off-label use of prochlorperazine maleate tablets after the licensed liquid version was discontinued in the UK. Accessed July 2025]. Accessed July 2025]. Accessed July 2025].
Inconsistencies : data should be formatted and labelled in a well-defined way, as ambiguity would trick both humans and models. Data traceability and immutability : meticulously documenting metadata pertaining to data sources, quality and context, to provide AI applications with the necessary contextual information during data processing.
Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained.
It’s approved by the Food and Drug Administration to treat Type 2 diabetes and may be prescribed off-label for weight loss. The long-term side effects of Mounjaro haven’t been well documented but may include an increased risk of gallstones. It’s injected under the skin once per week to help control blood sugar levels.
Because of those effects, Mounjaro is sometimes prescribed off-label for weight loss. This means the Aetna plan will only cover Mounjaro if the patient’s medical provider provides documented proof that the person meets certain requirements, such as a diabetes diagnosis or concerning blood glucose levels.
Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. It builds on drug calculations topics previously described (1), including guidance documents (2–5). Labeling for the primary and secondary labels are determined.
It’s 2025. And then how do you develop documents to basically get approval from the FDA to study your drug in humans? And ultimately, it’s to ensure we get the data because the data are ultimately what turns into your FDA approved label and demonstrates what you need. So, good talking to you.
While the European Medicines Agency mandated pre-treatment DPD testing in Europe as early as 2020, and the UK’s National Health Service followed suit the same year, the US only reached a consensus in 2025. Accessed July 21, 2025. Accessed July 21, 2025. Accessed July 21, 2025. European Medicines Agency. link] NHS England.
The CRL was received after OLC’s initial Prescription Drug User Fee Act date of June 28, 2025, and cited for deficiencies that are unrelated to OLC itself. The manufacturer reported that, as part of the NDA review, they have not highlighted any technical concerns related to the submitted documentation or testing of OLC. June 30, 2025.
Compliance & documentation : Ensuring scientific interactions, data sharing, and materials comply with regulatory and ethical standards, monitoring for compliance risks. But by 2025, many have moved beyond experimentation and are actively integrating various tools and software into their workflows.”
Our 2025 Medication Calculations quiz is now available. Since medications are usually dosed milligrams per kilogram, learn to consistently convert and document the patients weight in kilograms. Read the medication label carefully: This is a critically important step and one that often leads to errors and potential patient harm.
Existing policies often feature explicit exclusions for non-FDA approved products or harm from off-label use. Implement and meticulously document robust quality control and assurance processes internally. May 30, 2025. May 21, 2025. Pharmaceutical Commerce. Development & Approval Process | Drugs. Founder Shield.
Stage 1: design the compounding blueprint Establish a complete plan including ingredients, packaging, calculations, labeling, and patient-specific factors. Finalize documentation with full traceability and ensure preparations are quarantined until verified. Check out the full article here !
Robert Barrie July 15, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Hong Kong-listed Sino already owns a 4.91% stake courtesy of an investment in November 2024. Credit: Na_Studio via Shutterstock. At the time, Sino spent 142 million yuan ($19.80m) to initiate its ownership involvement with the biotech.
Medicare also doesn’t cover medications for off-label use except when treating cancer. As of 2025, about 13–14 Medicaid state plans cover at least one GLP‑1 receptor agonist. Your healthcare provider may need to share your body mass index (BMI) and other documentation to show that you’re following a weight loss diet and exercise plan.
If your healthcare provider prescribes Ozempic for weight management, which is an off-label use, insurance isnt as likely to cover it. Restrictions on off-label use: Insurance plans may not cover a medication prescribed off-label , that is, if its not prescribed for its FDA-approved use. affected by a shortage).
For example, in 2025, Aetnas Standard Plan and Humanas Medicare Advantage Plan include Paxlovid in their formularies. The drugs label states that it is indicated for COVID-19 treatment only and not prophylaxis against it. Coverage of Paxlovid by insurance plans is unpredictable and differs from one plan to another.
By 2025, healthcare data is projected to grow at an annual rate of 36% - outpacing industries like manufacturing, financial services, and media by as much as 11%. Recent analyses from RBC Capital Markets estimate that healthcare accounts for approximately 30% of global data production.
Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. If data are excluded because of data quality issues, the rationale and criteria for the exclusions should be documented in the DCP.
FDA notes that the sale or transfer of a 510(k) may involve changes to labeling, such as the name of the place of business and/or the device brand and model name, which likely requires a new unique device identifier (UDI) and as such will also require an update submission to FDA’s Global Unique Device Identification Database (GUDID).
In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. It is focused on the nutrients in the food product rather than on it overall nutritional “quality.”.
This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults.
In fact, the priority designation for the final rule is labeled as “economically significant.” Finally, CDRH would need to ensure alignment on existing guidance documents and regulations that refer to the QSR or 21 C.F.R. Dr. Shuren further elaborated that he hopes the final rule will be “out by the end of this year.”
It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents. The draft guidance indicates that this timetable will be announced by September 30, 2025. These content elements precisely follow the De Novo request content described in 21 C.F.R.
Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment. 803), Reporting of Corrections and Removals (21 C.F.R. §
Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA).
Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents. Would any such failure to meet DAP goals be reflected in labeling? 510(k) submission, De Novo classification request, Premarket Approval (“PMA”) application).
There are important considerations if the DHTT is classified as a medical device, which may change the level of regulatory controls and evidentiary requirements to support its appropriate use, such as off-label versus on-label use of a device with prior marketing authorization. Global Strategy on Digital Health 2020-2025.”
There are important considerations if the DHTT is classified as a medical device, which may change the level of regulatory controls and evidentiary requirements to support its appropriate use, such as off-label versus on-label use of a device with prior marketing authorization. Global Strategy on Digital Health 2020-2025.”
We are conducting an open-label, dose-escalation, phase I/II study PDC-LUNG-101 assessing the safety, tolerability, immunogenicity, and the preliminary clinical activity of therapeutic cancer vaccine PDC*lung, associated or not with anti-PD1 treatment in patients with non-small-cell lung cancer (NSCLC).
To date, neither FDA nor HHS has issued a guidance document describing circumstances in which the agencies will consistently grant waivers, as required under FDC Act 804(j)(2). Final Rule, Importation of Prescription Drugs , 85 Fed. 62,094, 62,097 (Oct. FDA has, however, set forth on its website a policy for personal importation.
Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act This final guidance replaces previous draft and final guidance documents on food allergen labeling that FDA issued in November 2022, which we discussed in a previous post. By Sophia R.
Javitt On May 8, 2025, FDA announced the successful completion of a generative artificial intelligence (AI) scientific review pilot program aimed at accelerating the review process and an aggressive timeline to rollout the use of AI tools across the Agency. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M.
Gaulkin & Ritte van Laack Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here , here , and here ). non-standardized foods), their labeling must bear the common or usual name of the food, if such a name exists.
MoCRA includes several self-executing requirements, such as registration and product listing, adverse event reporting requirements and labeling for adverse event reporting. If FDA meets those deadlines, 2025 will be a busy year for both FDA and industry. FDAs report card therefore shows a big Incomplete.
Kaisers 2025 Comprehensive Formulary documents for commercial insurance and Medicare Part D show which drugs their plans will generally cover, as long as theyre medically necessary. Ozempic is included, although the document notes that it requires prior authorization. What does that mean?
In contrast, the 2022 proposed redefinition focused on food groups recommended by nutrition science and the Dietary Guidelines (DGs), 2020-2025. Under the proposed rule, any raw whole fruits and vegetables could be labeled healthy no matter the level of added sugars, sodium, or saturated fat.
For fiscal year 2025, which began on October 1 and runs through September 30, 2025, the standard fee is $7,301. Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days.
Pharmacists and clinicians should document each injections brand name and batch number to ensure traceability and meet pharmacovigilance requirements. Long-term open-label extensions beyond one year are necessary to confirm sustained efficacy and immunogenicity. Accessed April 2025]. However, several knowledge gaps persist.
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
25] There have also been documented cases of improved egg quality and spontaneous pregnancies following PRP, both naturally and through IVF. Vitamin D supplementation reduces thyroid peroxidase antibody levels in patients with autoimmune thyroid disease: An open-labeled randomized controlled trial. Published 2025 Mar 20.
The gray box at the top of the document at this link shows the change in position. Were not trying to bury the lead here, but the battle of labeling these surgical and drug treatments is a political one. The EO and DOJ memo were followed by a May 1, 2025 announcement of a report from the U.S. See United States v. Facteau , 89 F.4th
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