The FDA has added five new topics to its list of guidance topics it expects to publish this year. Guidance documents represent the FDA’s current thinking on a specific topic. The agency is taking public comments here: https://ow.ly/U5KC50SueNO
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Dedicated Academician Turned Medical Writer || 10+ years of experience || Passionate about drafting Medical / Scientific documentation || Seeking New Challenges
An FDA guidance document summary has a typo. We All Make Mistakes: It's How We Learn and Grow That Matters Source: https://lnkd.in/gidnJde5
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Director of Clinical Research Operations @ the University of Pennsylvania- Abramson Cancer Center Clinical Research Unit
View all Official FDA Guidance Documents and other Regulatory Guidance: You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period: https://lnkd.in/eAfW-r53
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ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs, Guidance for Industry JANUARY 2024: This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion that can result in final approval on the earliest lawful approval date. This revision incorporates the performance goals currently outlined in the GDUFA III commitment letter and describes how FDA will handle requests for final approval and amendments to tentatively approved ANDAs subject to GDUFA III performance goals. This revised final guidance replaces the guidance of the same title issued in September 2020.
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Must-Read: FDA just released draft guidance on informed consent. This much-needed guidance aligns with the agency’s expanding patient-first approach, providing recommendations to break through jargon to improve participant comprehension. Here’s what you need to know: https://lnkd.in/gMsxRZh4
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Everyone is talking about the new FDA Guidance on diversity in #clinicaltrials. Here, Denise N. Bronner, Ph.D., breaks down what's good AND bad about the new guidance. https://lnkd.in/gTcTpg9T #diversityinclinicaltrials #clinicaltrialdiversity
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ELIQUENT Life Sciences provides timely insights. Here's what new in Informed Consent.
ELIQUENT Experts, Liz Oestreich and Tom Berry, examine a new FDA guidance on the importance of obtaining informed consent. Read their analysis at https://lnkd.in/gGRfTpcs
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The FDA has made changes that will go into effect in February 2026 - will you be ready for these updates? Get a brief overview of what these changes could mean for your business by reading our blog today: https://lnkd.in/gveShEq5
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When responding to FDA 483 observations that you believe are inaccurate, your response should always provide the facts and explanation needed to explain why the observation is not wholly accurate. You should always support your claims and response to 483 observations with facts and data. Avoid unsupported, unexplained assertions because they are of no value to the FDA's analysis of the response.
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If you don't pass a test on your first attempt, its not the end of the road! It may just take a re-visit of how to close your knowledge gaps and weigh the effort required to achieve your desired result. Review cycles for all types of medical products at #FDA, whether novel or biosimilar/generic, are not too different. Check out our latest insight on the need-to-know for when a product application receives a complete response letter, and what it means for re-considering launch plans and product access strategies. #CRL #Regulatorystrategy #Launchplanning #Marketaccess
NEW RESOURCE: #AvalereExperts Michelle Ofori, J.D. and Mark Von Eisenburg, MS explain how a complete response letter from the FDA can impact a sponsor's product access timeline and strategy: https://lnkd.in/gSandJnG
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Comments were due last week on the FDA's LDT proposed rule. In a recent blog post, Allyson Mullen writes about the readiness of the FDA to implement the rule, should it be published in April. Read the blog post here: https://lnkd.in/ekFdrVm5 #fdalawblog #medicaldevices #invitrodiagnosticdevices
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