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The advent of the first generic GLP-1 drugs could help Medicare negotiate a lower price for the highly sought after diabetes and obesity medication semaglutide , according to experts familiar with the price-negotiation program and STAT’s review of documents from the first round of negotiations.
In an unusual move, an audit of commercial health plans by Tennessee officials found that Express Scripts, one of the largest pharmacy benefit managers in the United States, violated state laws in its dealings with pharmacies, according to newly released documents.
The rise of large language models that can efficiently summarize text has fueled the rapid development of companies using the technology to take documentation burden off overworked clinicians. Then, the provider must go through and add or edit the text that the Eleos software generated to their final note.
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.
Two decades ago, when I first began practicing emergency medicine, patient documentation was a manual process. I would write on carbon-copy forms that were later stored in the belly of the hospital, in archives, as patient files.
Abridge, which has emerged as one of the leaders amid the boom in companies using technology to streamline clinical documentation, announced today it has over 100 health system customers, including big names like Duke Health, Johns Hopkins, and Mayo Clinic. Read the rest…
By John W.M. Claud & Michelle L. Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. One area drawing increasing attention is how these changes will affect the drug development and review process.
Canadian officials have obtained a court order that requires Express Scripts to produce documents in connection with an investigation into whether the pharmacy benefits manager violated antitrust laws. The Competition Bureau is examining whether the company forced or induced Canadians to use its own pharmacies.
By offering comprehensive and audit-proof documentation, the platform aims to simplify regulatory approvals and reduce time-to-market for pharmaceutical companies. It contains revision dates, test results, certifications, and regulatory documentation. However, access to full documentation is restricted to existing customers.
Rising expectations for scientific rationale One consistent theme across FDA communications, including 483s, Warning Letters, and guidance documents is the demand for sound scientific justification behind design and operational decisions. Interventions were neither documented nor risk-assessed.
Quality Documentation and Manufacturing Expertise CDMOs are experienced in generating high-quality documentation required for regulatory submissions and have extensive expertise in drug development and manufacturing.
From detecting cancer and remote patient monitoring to streamlined documentation and automated prior authorizations, here are 15 proven clinical uses of AI — with results: Nearly 2,000 physicians and advanced practice providers at Altamonte Springs, Fla.-based based AdventHealth are using Nuance’s DAX Copilot ambient AI scribe.
Understanding FDA Product Specific Guidances Product Specific Guidances are documents issued by the U.S. Global Harmonization Efforts There are ongoing efforts to harmonize bioequivalence standards and PSG-like documents across regulatory agencies worldwide. This could further streamline the development process for certain products.
The brief, 20-page document, instead, focuses on AI models used to produce data that supports regulatory decision-making about the safety, effectiveness, or quality of drugs. The guidance does not, however, capture how AI is being used in drug discovery, the process of identifying and designing molecules, or in operational efficiency.
By systematically monitoring and analyzing these documents… Patent filings represent one of the most valuable yet underutilized sources of competitive intelligence in the pharmaceutical industry.
Building internal safety protocols and maintaining comprehensive documentation are essential to meet these environmental and safety obligations. Regular audits, proper documentation, and legal vetting of contracts are necessary to avoid such issues. Falling short can mean serious consequences, including product recalls or export bans.
Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. See 21 C.F.R. For example, in an October 13, 2023 WL to ReNovo, Inc.,
He further highlighted the importance of thorough documentation, communication with regulators, and the need for a comprehensive understanding of the revised Schedule M guidelines.
He also stressed the importance of reviewing batch records and analytical records and the need for clear documentation practices. Dr Khurana stressed the importance of risk-based testing and the need for proper documentation. He mentioned the role of quality assurance in ensuring these practices are followed.
Ancient civilizations in China, Egypt, and India documented the use of herbs for healing. This patent was later revoked after the Indian government challenged it, citing ancient Ayurvedic texts that documented this use of turmeric. patent for the use of turmeric in wound healing.
Document 9286/25. The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. Brussels: Council of the European Union; 2 June 2025. Interinstitutional File: 2023/0131 (COD).
And so Hassan called on GSK to return the product to market and, meanwhile, asked for numerous documents concerning pricing, rebates and communications with regulators. This marks the second time in recent months that GSK has angered a lawmaker over the asthma inhaler switch.
For example, GPS-enabled systems can log client visits, verify completed appointments, and document time spent at each location. GPS tracking helps sales organisations achieve these goals by providing a clear record of when and where sales representatives have been.
.” She points out that, “Special attention is required when handling data related to children and minors, ensuring that verifiable consent is obtained from guardians and that consent management is robust and well-documented.
Above the evidence-based professional recommendations on disease (i.e., what generally works) lies the foundation of each patient's understanding, needs, and expectations of their health, accounting for their lived realities such as financial constraints, cultural beliefs, and family responsibilities.
Other documented pharmacological causes of anisocoria include nebulized ipratropium bromide and scopolamine (14-19). EM Clinicians should consider exposure-related anisocoria in the differential diagnosis of infant patients with acutely asymmetric pupils.
Understanding Google Patents Google Patents is a search engine that allows users to search the full text of patent documents from around the world. This article explores the limitations of Google Patents in this context and suggests alternative approaches.
Indian companies will need to enhance their quality control mechanisms, data management systems, and documentation practices to comply with these demanding standards. Moving into the innovative drug space requires meeting the stringent regulatory standards of agencies like the FDA and EMA.
Whether it’s improving patient counseling or mastering SOAP note documentation, goal-setting helps you stay focused and measure progress throughout your APPE rotations pharmacy journey. Document Everything for Self-Evaluation and Career Growth Keep a rotation journal or digital log. Preceptors can become mentors and recommenders.
“It is not justifiable to compare pharma products, where a lot of work has already been done and well-documented with international harmonisation (e.g., He stresses the need for a collaborative effort between industry players and regulatory bodies to establish clear guidelines that ensure the safety and efficacy of products.
The authors found references to skin tone, pigmentation, or race in 4% of the documents submitted before the FDA made its suggestion to diversify skin tone testing in 2013.
Without documented patient consent: Claims can be denied Medicare reimbursement is forfeited Practices face potential audits, penalties, or disqualification from CMS programs Trust between providers and patients erodes These consequences are what no executive or practice manager can afford to ignore.
The added requirements will not only prolong approval timelines but also increase operational costs, as companies must invest in specialised compliance teams and detailed documentation for each certification layer.
According to court documents reviewed by Becker’s , Mr. Khan owned and operated labs in Texas as part of a conspiracy to submit false reimbursement claims for COVID-19 testing on samples that were never collected, mostly from uninsured patients.
To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.
The FDA should require that sponsors document mechanisms for post-market surveillance, root-cause investigation of errors or malfunctions, and audit trails that track data inputs, model updates, and user interactions. 56 ,57 ,58 Finally, comprehensive documentation is essential for reproducibility and public confidence.
According to the 168-page document, the Medicines and Healthcare products Regulatory Agency (MHRA) will adopt 'a more pro-innovation approach to regulation, […] The post MHRA and NICE to join forces to speed up medicines approval appeared first on The Pharmacist.
hour workshop provided participants with direction, supplementary documentation, and hands-on learning, ensuring they were well-equipped to meet compliance requirements. He provided detailed responses on compliance challenges & documentation requirements. Close to 200 participants attended the online workshop.
Secure Document Uploads – Protects sensitive health data while enabling necessary file sharing. This keeps sensitive documents off of email or other forms of communication that could end up in front of the wrong person. Note Taking Feature – Allows pharmacists to document important details during interactions.
The document marks the first publication by the Obesity Management Collaborative UK, a professional network established in 2024 to support clinicians managing obesity. We want GPs to have the basic knowledge to prioritise patient safety and demystify side effects.
Features like eCOA libraries with prebuilt instruments and the ability to autogenerate code and documentation accelerate development without sacrificing quality. Next-generation eCOA platforms not only minimise sponsor burden, but they also introduce tremendous end-to-end workflow efficiencies.
Based on our on-ground experience, the following patterns are frequently observed: Design basis weaknesses: Facilities often lack well-documented scientific rationales or fail to present a robust justification for design choices, procedural controls, and process parameters.
27 of this year to meet the requirements, as long as they are making documented efforts to finalize data connections, of course. In fact, wholesalers and repackagers had until May 27, 2025 (following this day, full-unit traceability would be mandatory), a date that has officially passed.
Further along in the harmonisation process, data scientists identify and manage exact and related documents, preventing data duplication and ensuring that only the most relevant information is retained.
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