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‼️FDA JUST RELEASED ‼️ Facility Readiness: Goal Date Decisions Under GDUFA Guidance for Industry ➡️This guidance provides information to applicants on how #FDA intends to assign a goal date based on a facility’s #readiness for #inspection as certified on Form FDA 356h, submitted as part of an original abbreviated new drug application (#ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). ➡️ This guidance explains how FDA incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to #reauthorization of the Generic Drug User Fee Amendments (#GDUFA), as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter). This guidance does not apply to: • Facilities involved in bioequivalence and clinical studies used to support an application • Amendments submitted after a complete response or tentative approval letter • Supplements or amendments to a supplement #FDA #regulatory If you like this post follow me on LinkedIn

Last week, the US Food and Drug Administration (FDA) published a draft guidance that would replace the accelerated approval portion of its broader guidance covering its various expedited pathways. The FDA recommended that sponsors talk to regulators early in their drug development. ➡️ Learn more: https://lnkd.in/e52PyrBU #drugdevelopment #ANDA #FDA

📌 NEWS | FDA Guidance Update ↪ The FDA has just released a revision of the Guidance for Industry: Amendments to Abbreviated New Drug Applications (#ANDA) under #GDUFA (Revision 1). ↪ This updated guidance outlines the classifications and categories of amendments, explaining how #submissions may affect the goal dates for application assessments. It applies to amendments for both Abbreviated New Drug Applications (#ANDAs) and Prior Approval Supplements (#PASs), under Section 505(j) of the FD&C Federal Food, Drug, and Cosmetic Act. ↪ Submissions will now be classified based on their content, with goal dates set according to the assigned classification. 📄 Stay informed by reading the full guidance here: https://bit.ly/3XAWO0O 📧 Do you need help in your regulatory affairs? Contact us at: info@asphalion.com #FDA #Pharma #ANDAs #DrugApproval #RegulatoryAffairs #GDUFA #RA #WeAreAsphalion #WeCare #KnowledgeFromExperience https://bit.ly/4esrBDw

📌Therapeutic Goods Administration (𝗧𝗚𝗔) 𝗔𝗱𝗼𝗽𝘁 𝟭𝟭𝟮 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲𝘀, enhancing the regulatory framework for therapeutic goods in Australia by leveraging the work done by international regulatory counterparts. 𝙃𝙚𝙧𝙚 𝙖𝙧𝙚 𝙩𝙝𝙚 𝙠𝙚𝙮 𝙩𝙖𝙠𝙚𝙖𝙬𝙖𝙮𝙨: 🔸 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗔𝗹𝗶𝗴𝗻𝗺𝗲𝗻𝘁: The TGA aligns with international regulatory counterparts, such as the European Union (EU) Guidelines, International Conference on Harmonisation (ICH), and the Food and Drug Administration (USA). 🔸𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲 𝗔𝗱𝗼𝗽𝘁𝗶𝗼𝗻: Before adopting any guideline, the TGA undertakes extensive internal and external consultations to ensure consistency with Australian requirements. 🔸𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝘁𝗼 𝗠𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀: The guidelines apply not only to prescription medicines but also to over-the-counter (OTC), complementary, and some listed medicines. 🔸𝗗𝗲𝘃𝗶𝗮𝘁𝗶𝗼𝗻 𝗝𝘂𝘀𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻: While the guidelines are not mandated by legislation, any deviation from them in an application must be justified. This reflects a move towards a harmonized approach to regulatory guidance globally. 𝙃𝙚𝙧𝙚'𝙨 𝙩𝙝𝙚 𝙇𝙞𝙣𝙠🔗: https://lnkd.in/eAaj3nK6 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for 𝘆𝗼𝘂𝗿 time and please 𝗟𝗶𝗸𝗲 👍, 𝗦𝗵𝗮𝗿𝗲, and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁 #medicaldevices #invitrodiagnostics #combinationproducts #mlv #qualityassurance #regulatoryaffairs #pharmaceuticals

From Emily Hayes in Regulatory Affairs Professionals Society (RAPS) News: “Misinformation has been a significant impediment to use of safe and effective lower priced biosimilars, and the revised guidance will help ensure that sponsors engage in truthful and non-misleading communications regarding biosimilars,” wrote the Biosimilar Council…” READ the full article, titled: ‘Stakeholders urge FDA to strengthen guidance on biosimilars promotions, stop bad actors’ FDA Association for Accessible Medicines #biosimilars #regulatory #fda #medicines

FDA publishes final guidances Q2(R2) and Q14 The Food and Drug Administration (FDA) announced in March 2024 the availability of the following fiinal guidances for industry on its website. Q2(R2) Validation of Analytical Procedures, which  provides a general framework for the principles of analytical procedure validation. Q14 Analytical Procedure Development, which describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug product. Both documents were made available for download on the ICH website at the end of 2023. The European Medicines Agency (EMA) has announced that Q14 is effective from 14 June 2024 #RegulatoryAffairs #RegulatoryGuidance #QualityAssurance The documents can be downloaded using the links shown below: https://lnkd.in/gMwM7QBH https://lnkd.in/gekJKHq4

Understanding Drug Safety: EMA vs. USFDA on Nitrosamine Guidelines Explore key points about how European and U.S. agencies manage drug safety for nitrosamines: - Scope: EMA covers a wide range of products; USFDA focuses on specific drug types. - Safety Measures: Both discuss safety, but with different priorities and details. - Testing and Risk: EMA focuses on developing methods; USFDA emphasizes testing validation. - Setting Safety Limits: EMA uses broad data; USFDA sets specific intake limits. For a full comparison, check the linked table in the comments. 🔍 Any discrepancies or thoughts? Drop a comment below! 🔄 Feel free to share this post! #Regulations #pharma, #regulatory #pharmaindustry #EMA #fda #eu #CDSCO #Healthcare #kaust #eda #algeria #safety #nitrosamine #usfda #sfda #gcc #middleeast #knowledgesharing #learning

The FDA has released a new draft guidance this week on the diversity action plans (DAP) that were mandated in Section 3602 of Food and Drug Omnibus Reform Act of 2022 (FDORA) for phase 3 and pivotal trials for drugs. This guidance replaces the previous draft that was released in April 2022 ( that replaced a draft guidance from 2016 and has significantly expanded information on the implementation of this new requirement that will go into effect 180 days after a final guidance is published and on the format/content of the plans themselves. New information of note in this draft includes specific mention of how to provide updates on how you are meeting goals of your DAP in IND annual reports during development as well as a section encouraging sponsors to publicly post key information on their DAP. The draft guidance is open for public comment for 90 days. It will be interesting to follow any updates in the final guidance once published. https://lnkd.in/gvWv5JKk

📢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

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