American Nurses Association’s Post

When will the #FDA finalize their ruling on the proposed #ESD #ban; effectively prohibiting the practices of #CESS in Massachusetts & the #JudgeRotenburgCenter ? In contrast to their 2022 ruling; this year the FDA has ensured they have authority to maintain the ban and it will not be overturned; if approved. Keep an eye on the FDA press announcements at the link in this post & listen to #NDNABAthePodcast with Martin Slyngstad and Dan more details as the events unfurl. https://lnkd.in/g2fvTWih #StopTheShock #BanESDs You can also visit Bearded Behaviorist ‘s profile for more information on the subject matter. *CONTENT WARNING* electric shock discussed

Deep dive into the latest Health Authorities - MHRA, USFDA, ANVISA, SAMR, NMPA, EFSA, etc. - crucial roll outs from last week. Dive into the details with Freyr Regulatory Roundup: https://lnkd.in/eGy3iEsE #RegulatoryUpdates #HealthAuthorities #LifeSciences #FreyrRegulatoryRoundup #FreyrSolutions

Dr. Robert Califf's recent announcement about the FDA's intention to become a "more activist" agency reflects a strategic shift towards a proactive regulatory stance. “We're just really trying to equip the FDA to be ready for the next decade, which is predictably going to be a decade of tremendous change in the external environment.” This could indicate a greater emphasis on robust oversight, enforcement, and intervention in order to ensure public health and safety. Such an approach might have wide-ranging implications across industries regulated by the FDA, potentially driving changes in compliance, innovation, and risk assessment strategies. https://lnkd.in/gfga3UHq

Gain insights into the latest Regulatory updates released by global Health Authorities (HAs) – USFDA, MHRA, TGA, NMPA, FSC, PMDA, etc. Follow Freyr Regulatory Roundup for weekly updates. https://lnkd.in/g5pxPt3z #RegulatoryUpdates #HealthAuthorities #FreyrRegulatoryRoundup #FreyrSolutions

https://lnkd.in/eyYCrNQF The 3 Things The FDA Needs to Fix: Get Their Act Together! #MilettiLaw #LegalServices #UnusuallyMotivated #MostJackedAttorneyNYC #LegalBranding #LegalHR #NewYorkLawyer #BrooklynLawyer

How do you ensure your DMC meets regulatory agency expectations? Join our 7 March webinar to learn from our 20+ years in the field:

Hello GxP folks, It's great information here from the FDA on the new draft guidelines for "RRA: Remote Regulatory Assessment.". This draft guidance provides that industries can be audited remotely when the FDA cannot conduct an inspection due to travel limitations brought on by public health emergencies. Also, if any NC is found during the RRA, the FDA issues 483 and conducts a subsequent inspection. Be compliance every time and protect human health. #fda #regulatorycompliance #lifescienceindustry #qualityassurance

Health Authorities - MHRA, USFDA, ANVISA, SAMR, NMPA, EFSA, etc. rolled out crucial updates last week. Dive into the details with Freyr Regulatory Roundup: https://lnkd.in/eGy3iEsE #RegulatoryUpdates #HealthAuthorities #LifeSciences #FreyrRegulatoryRoundup #FreyrSolutions

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.

HOW USFDA CLASSIFY INSPECTIONS? Following a USFDA inspection, the agency evaluates the inspection findings to determines if the facility is in compliance with applicable laws and regulations and classifies the inspection. The three classifications are: 1. NO ACTION INDICATED (NAI): Which means no objectionable conditions or practices were found during the inspection. 2. VOLUNTARY ACTION INDICATED (VAI): Which means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. 3. OFFICIAL ACTION INDICATED (OAI): Which means regulatory and/or administrative actions are recommended. The agency maintains an inspection #data dashboard# that includes final inspection classifications (updated weekly) on FDA.gov. Once an inspection has been classified and it is considered closed it is added to this database. The agency determines the final inspection classification by evaluating: 1. Information collected during an inspection. 2. Information provided by the facility following an inspection. Inspection classification recommendations from investigators are an important factor in the evaluation and in the classification process. Additional information is considered to determine the final inspection classification, including: 1. The facility’s response to inspectional observations highlighted in Form FDA 483. 2. The company’s proposed or completed corrective actions.  REFERENCE: USFDA.