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The FDA’s new NDA filing checklist aims to prevent delays and improve transparency in drug approvals. Learn how this update impacts sponsors and review efficiency: emmainternational.com #FDAGuidance #Pharma #RegulatoryCompliance

The FDA’s draft guidance on radiopharmaceutical dosing is redefining how cancer therapies are developed. Can innovation and safety coexist? Read our latest blog: emmainternational.com #Radiopharmaceuticals #Oncology #FDAGuidance #Innovation

We read the FDA’s new draft guidance on dosage optimization for radiopharmaceuticals with great interest — but what’s missing? Dr. Amandine Manon shares key gaps and how sponsors can address them. 🎥 Watch: ow.ly/gk4R50X96a6 #Certara #FDAGuidance #DrugDevelopment

The FDA’s new draft guidance on dosage optimization for radiopharmaceuticals brings key updates for drug developers. Dr. Amandine Manon breaks down what’s changed—and why it matters. 🎥 Watch: ow.ly/gk4R50X96a6 #Certara #FDAGuidance #DrugDevelopment

ADC programs underway? Understanding the regulatory approval process is key. Check out our newest blog post that breaks down the FDA guidance on ADCs! 🔗buff.ly/EeZLENs #FDAguidance #ADCs #RegulatoryApprovals

The FDA’s new draft guidance on oncology radiopharmaceuticals outlines key steps for dosage optimization. In this short video, Dr. Amandine Manon shares what it means for sponsors developing these therapies. 🎥 Watch: ow.ly/gk4R50X96a6 #Radiopharmaceuticals #FDAGuidance

Discover the 5 key FDA cybersecurity standards every medical device manufacturer must know. Watch here: ▶️ youtube.com/watch?v=B--_yc… #MedicalDeviceCybersecurity #FDAGuidance #CybersecurityStandards #ISO14971 #IEC62304 #BlueGoatCyber

FDA warns Whoop over its blood pressure feature — a reminder for med spas + wellness businesses: claims matter, and compliance is critical. Read the breakdown: lengealaw.com/fda-issues-war… #MedSpaLaw #FDAGuidance #WearableTech

FDA Project Catalyst offers AID meetings for small companies developing anticancer therapies. Get product advice, education & regulatory direction. Register now: surveymonkey.com/r/G5Y8Y9K #FDAGuidance #CancerResearch

The FDA has issued final guidance on the Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations. - #Biosimilars #TherapeuticProteins #FDAGuidance #DrugDevelopment #Pharmaceuticals #QualityAssessment

Navigating the Confusion: Updated COVID-19 Vaccines and Flu Shots This Fall #COVID19vaccines #flushots #FDAguidance #vaccineaccess breakingon.com/health/navigat…

FDA Project Catalyst offers AID meetings for small companies developing anticancer therapies. Get product advice, education & regulatory direction. Register now: surveymonkey.com/r/G5Y8Y9K #FDAGuidance #CancerResearch

The FDA has released draft guidance that could reshape how organizations approach radiopharmaceutical development. Don't miss your chance to weigh in: fda.gov/regulatory-inf… #RadiopharmaceuticalDevelopment #FDAGuidance #Oncology #Radiopharmaceuticals #NuclearMedicine

📢 NEW: FDA Project Catalyst offers AID meetings for small companies developing anticancer therapies. Get product advice, education & regulatory direction. Register now: surveymonkey.com/r/G5Y8Y9K More info: fda.gov/OCECatalyst #FDAGuidance #CancerResearch

📢 NEW: FDA Project Catalyst offers AID meetings for small companies developing anticancer therapies. Get product advice, education & regulatory direction. Register now: surveymonkey.com/r/G5Y8Y9K More info: fda.gov/OCECatalyst #FDAGuidance #CancerResearch

📢 NEW: FDA Project Catalyst offers AID meetings for small companies developing anticancer therapies. Get product advice, education & regulatory direction. Register now: surveymonkey.com/r/G5Y8Y9K More info: fda.gov/OCECatalyst #FDAGuidance #CancerResearch

We recently recorded a fantastic conversation with Karandeep Singh Badwal, Regulatory Affairs & Quality Consultant, for an upcoming Med Device Cyber Podcast episode! Stay tuned—we’ll let you know when the episode goes live soon! #MedDeviceCyberPodcast #FDAguidance #BlueGoatCyber

FDA releases final guidance on developing drugs for early Lyme disease.  Guidance focuses on localized & disseminated disease; covers trial design, safety & efficacy; & aims to support drug development. Learn more: fda.gov/regulatory-inf… #LymeDisease #FDAGuidance

FDA Published a warning letter for Staska Pharmaceuticals, Inc. fda.gov/inspections-co… #FDAGuidance #FDASafety #FDAAlert #FDARegulations #FDACompliance #FDAReview #FDAApproval #FDAInspection

FDA Published warning letter about Sterling Distributors fda.gov/inspections-co… #FDAGuidance #FDASafety #FDAAlert #FDARegulations #FDACompliance #FDAReview #FDAApproval #FDAInspection

The FDA’s new NDA filing checklist aims to prevent delays and improve transparency in drug approvals. Learn how this update impacts sponsors and review efficiency: emmainternational.com #FDAGuidance #Pharma #RegulatoryCompliance

The FDA’s draft guidance on radiopharmaceutical dosing is redefining how cancer therapies are developed. Can innovation and safety coexist? Read our latest blog: emmainternational.com #Radiopharmaceuticals #Oncology #FDAGuidance #Innovation

We recently recorded a fantastic conversation with Karandeep Singh Badwal, Regulatory Affairs & Quality Consultant, for an upcoming Med Device Cyber Podcast episode! Stay tuned—we’ll let you know when the episode goes live soon! #MedDeviceCyberPodcast #FDAguidance #BlueGoatCyber

Our team understands that successful engagements require a comprehensive understanding of not just FDA regulations, but also your unique business goals and challenges. #EMMAInternational #FDAGuidance #ConsultingExperts #HolisticApproach

🚨 🥁Guidance alert 👉🏼The US FDA @FDAOncology released a new FDA draft guidance today on 👉🏼Tissue Agnostic Drug Development in Oncology 1/3 #PrecisionMedicine #FDAGuidance #tissueagnostic #oncology #drugdevelopment fda.gov/regulatory-inf…

ICYMI: FDA issued draft guidance, Tissue Agnostic Drug Development in Oncology. A tissue agnostic drug can be used to treat multiple types of cancer and raises unique scientific issues. Download & submit comments ⤵️ fda.gov/regulatory-inf… #FDAGuidance #CancerMoonshot

Another new FDA draft guidance today: Tissue Agnostic Drug Development in Oncology fda.gov/regulatory-inf… #FDAGuidance #tissueagnostic #oncology #drugdevelopment

We've issued draft guidance to assist sponsors in identifying optimal dosages for oncology drugs or biological products prior to submitting an application for a new use. Comments welcome. #OCEProjectOptimus #FDAGuidance fda.gov/regulatory-inf…

Takeaways | Making the Most of COVID Regulatory Changes via Denver Patent Partner Nicki Kennedy Learn more: kilpatricktownsend.com/Insights/Persp… #Patent #FDAGuidance #ProductDevelopment #PREPAct

FDA issued draft guidance on Considerations for Including Tissue Biopsies in Clinical Trials. fda.gov/regulatory-inf… #FDAGuidance

Final FDA guidance: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases. fda.gov/regulatory-inf… #FDAGuidance #OCEProjectOptimus

New video platform helps health and pharma advisers #fdaguidance #dtcadvertising #pagescience okt.to/g04K93

#FDAGuidance issued on developing drugs & biologics for adjuvant treatment of #bladder #cancer & #renalcell #carcinoma. 🔦 Bladder Cancer: bit.ly/3QW3D8T 🔦 Renal Cell Carcinoma: bit.ly/3QU5meN #blcsm #rcc

FDA Press Release: FDA Issues Draft Guidance on Conducting Multiregional Clinical Trials in Oncology fda.gov/news-events/pr… #FDAGuidance #cancer #drugdevelopment #clinicaltrials

FDA issues draft guidance on non-binding feedback on inspections seekingalpha.com/news/3434056-f… #FDAGuidance #FDA #medtech #medicaldevices #manufacturers #inspections

Today, we issued a draft guidance with recommendations on submitting NDAs/BLAs with oncology indications for review under the Real-Time Oncology Review. fda.gov/regulatory-inf… #RealTimeOncologyReview #RTOR #FDAGuidance

ICYMI: Our new draft guidance has recommendations on submitting NDAs/BLAs with oncology indications for review under the Real-Time Oncology Review (RTOR). fda.gov/regulatory-inf… #RealTimeOncologyReview #RTOR #FDAGuidance

New FDA draft guidance: Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials fda.gov/regulatory-inf… #FDAGuidance #cancer #immunotherapy #clinicaltrials

At the FDA, drugs and tweets don't mix #FDAGuidance #pharmaadvertising okt.to/Q3A80i

Final #FDAguidance posted: Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry. OCE technical leads were @ElaineChangMD and #DanielLee. #pcsm #prostatecancer bit.ly/38vhK3K