Patti Maguire’s Post

New FDA Draft Guidance for BIMO Inspections! On Wednesday, the FDA published a draft guidance for industry detailing the processes and practices for inspections of sites and facilities under the FDA’s Bioresearch Monitoring (BIMO) program. This guidance, aligned with section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act, highlights key aspects such as required records, information, and best practices for communication between the FDA and industry stakeholders. https://lnkd.in/eVkEcEsN #FDA #BIMO #IndustryStandards #RegulatoryAffairs #Pharma #Biotech 4o

'Stakeholders want the US Food and Drug Administration (FDA) to acknowledge that testing sites used for bioavailability (BA) and bioequivalence (BE) studies are often operated and audited by third parties who should also bare responsibility for compliance and maintaining the facilities. “Contracting third-party auditors can free up applicant personnel to conduct quality assurance activities and can bolster the independence of the audit,” the group argued. “We recommend FDA clarify in the Draft Guidance’s discussion of monitoring plans that although applicants can conduct the audit themselves, they may instead contract for a qualified third party to conduct the audit.”   Bristol Myers Squibb (BMS) also commented and said that as it is currently written, the guidance seems to require a formal auditor to conduct such audits. The drugmaker said such audits are often conducted by a Clinical Research Associate (CRA) and asked FDA to clarify the issue.' I would be curious to see how many CRAs will remain in the industry if they are made responsible for site audits and compliance. How would that work with all those inexperienced CRAs? Can you really ask them to do an audit for you? #CRA #FDA #siteaudits

In recent years, the widespread detection of nitrosamine contaminants in medicinal products has prompted regulatory bodies, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), to take action and address the issue. 💊 In this blogpost, you will learn about nitrosamine impurities, their causes, regulatory guidance, and strategies for risk evaluation and mitigation. 🔎✔️ 👉 https://hubs.li/Q02DRdSb0 #nitrosamine #FDA #EMA #Pharma

The clinical significance and real-life impact of a medication are better understood through Real-World Evidence (RWE) and Real-World Data (RWD), as controlled trials may not fully capture all practical applications of a drug. Regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are increasing their efforts to enhance the accessibility, quality, outcome harmonization, and governance of RWD through RWE frameworks and guidance documents. In continuation of such efforts, the FDA announced today (November 7, 2024) about the free public hybrid workshop on optimizing the use of RWE on December 12, 2024, from 12:30 pm to 5:00 pm (EST). Registration can be done using the link below before the deadline of December 6, 2024. #FDA #RWE #RWD #EMA #ClinicalTrials #DrugDevelopment #RegulatoryAffairs #MedicalWriting #BioPharma

Here are our initial thoughts on the just published Food and Drug Administration (FDA) final rule on laboratory developed tests. 

Center for Drug Evaluation and Research The Food and Drug Administration (FDA or the Agency) is announcing the availability of the guidance for industry entitled "Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions." This guidance describes the electronic submission of certain data and information in standardized formats. This information is used by the Center for Drug Evaluation and Research (CDER) in the planning of, and by FDA’s Office of Inspections and Investigations (OII) in the conduct of, BIMO inspections.

📢The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “𝑹𝒆𝒒𝒖𝒆𝒔𝒕𝒔 𝒇𝒐𝒓 𝑹𝒆𝒄𝒐𝒏𝒔𝒊𝒅𝒆𝒓𝒂𝒕𝒊𝒐𝒏 𝒂𝒕 𝒕𝒉𝒆 𝑫𝒊𝒗𝒊𝒔𝒊𝒐𝒏 𝑳𝒆𝒗𝒆𝒍 𝑼𝒏𝒅𝒆𝒓 𝑮𝑫𝑼𝑭𝑨.” 📄This guidance provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. The guidance reflects the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA III) and clarifies what matters are appropriate for requests for reconsideration. The guidance finalizes the draft guidance for industry of the same title issued on January 11, 2024. 𝐒𝐭𝐚𝐲 𝐢𝐧𝐟𝐨𝐫𝐦𝐞𝐝, 𝐬𝐭𝐚𝐲 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐭! #IndustryGuidance #RegulatoryAffairs #FDA #GDUFA #ANDASubmissions #PharmaUpdates #DrugApproval #PharmaceuticalIndustry #AdaptisPharma #HumanSafety #GenericDrugs #ANDA #regulatorycompliance #ANDAparking #USagent #APIMF #drugregulatory #USFDA #RegulatoryServices #PharmacovigilanceServices #UKMarkt #CanadaMarket #USMarket

important documents required for submission dossiers in JFDA The Jordan Food and Drug Administration (JFDA) published Guidance for the most important documents frequently requested in the drug dossiers submitted for registration with the Jordan Food and Drug Administration #regulatoryaffairs #regulatoryaffais #regulatoryaffairs #regulatoryupdates #regulatorystrategy #regulatoryrequirements #regulatory #regulatoryscience #regulatoryinsights #Jordan #regulatorysubmissions #submission #dossier #cmc #regulations #pharmaceuticalcompanies #cmc #drugs #compliance #diwakarshuklaregulatoryaffairs

important documents required for submission dossiers in JFDA The Jordan Food and Drug Administration (JFDA) published Guidance for the most important documents frequently requested in the drug dossiers submitted for registration with the Jordan Food and Drug Administration #regulatoryaffairs #regulatoryaffais #regulatoryaffairs #regulatoryupdates #regulatorystrategy #regulatoryrequirements #regulatory #regulatoryscience #regulatoryinsights #Jordan #regulatorysubmissions #submission #dossier #cmc #regulations #pharmaceuticalcompanies #cmc #drugs #compliance #diwakarshuklaregulatoryaffairs

important documents required for submission dossiers in JFDA The Jordan Food and Drug Administration (JFDA) published Guidance for the most important documents frequently requested in the drug dossiers submitted for registration with the Jordan Food and Drug Administration #regulatoryaffairs #regulatoryaffais #regulatoryaffairs #regulatoryupdates #regulatorystrategy #regulatoryrequirements #regulatory #regulatoryscience #regulatoryinsights #Jordan #regulatorysubmissions #submission #dossier #cmc #regulations #pharmaceuticalcompanies #cmc #drugs #compliance #diwakarshuklaregulatoryaffairs