Between 1995 and 2014, a majority of new drugs and medicines approved by the FDA recouped the average cost of drug development through net discounted sales within a decade of their approval, according to results from a recent retrospective study. “For these products, patents, data protection, and other regulatory exclusivities appear to provide brand-name drug makers with generous market protection,” Olivier J. Wouters, assistant professor of health policy at the London School of Economics and Political Science, and colleagues wrote. Jeff Craven reports for Regulatory Focus: https://bit.ly/3S8CMsi
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Join me and other FDA colleagues for this important SBIA webinar tomorrow (May 9) talking about the utility of GDUFA Pre-Submission Meeting ahead of your ANDA applications. Will be a good learning session for understanding the content of such meetings and how this can be helpful for the generic drug assessment process. #generics, #GDUFAmeetings
Redesigned Pre-Submission Meetings in GDUFA III
fda.gov
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Delving into 2023 drug approvals in our latest special report, we highlight a significant rebound in FDA approvals, particularly for Pfizer, with a noteworthy tally of seven new drugs. Following a subdued 2022 that witnessed only 37 new drug approvals—marking the lowest figure since 2016—the FDA experienced a resurgence, greenlighting an impressive 55 new drugs in 2023. This comprehensive list stands as the second-longest in FDA history, narrowly missing the single-year record of 59 approvals established in 2018. Read the full report! https://loom.ly/yewxcec #FierceBiotech #FiercePharma #FierceHealthcare #Pharma #Biotech #WeAreFierce
2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer
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Delving into 2023 drug approvals in our latest special report, we highlight a significant rebound in FDA approvals, particularly for Pfizer, with a noteworthy tally of seven new drugs. Following a subdued 2022 that witnessed only 37 new drug approvals—marking the lowest figure since 2016—the FDA experienced a resurgence, greenlighting an impressive 55 new drugs in 2023. This comprehensive list stands as the second-longest in FDA history, narrowly missing the single-year record of 59 approvals established in 2018. Read the full report! https://loom.ly/yewxcec #FierceBiotech #FiercePharma #FierceHealthcare #Pharma #Biotech #WeAreFierce
2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer
fiercepharma.com
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MedShadow Foundation Founder I FDA Consumer Representative I Speaker I Drug Side Effects Expert I Medication Risks & Benefits I DES Daughter
There’s a lot of health misinformation on the internet which can be very convincing. The FDA recently published guidelines for pharmaceutical companies requiring them to be more aggressive in addressing false claims about their medicines by also including a link to scientific research on that drug. Key takeaways: 💊Ignore personal and or sensational claims such as “a drug will save your life” 💊Check to see that all claims about medicine and supplements are based on real scientific research 💊Drug manufacturers must identify themselves as the maker of the drug and include a link to scientific research Are the medicines and supplements you take based on scientific research? #medicine #FDA
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The recent Public Consultation conducted by ANVISA marks a pivotal moment in the regulatory evolution of biological drugs. As the Brazilian regulatory authority strives to enhance clarity and harmonize standards with global guidelines, the implications are profound for players across the pharmaceutical spectrum. In this dynamic landscape, our legal experts, Daniela Guarita Jambor and Guillermo Glassman of SPLAW - Spiewak | Carneiro Advogados delve into the intricacies of the regulatory changes and their far-reaching consequences. Their comprehensive analysis sheds light on the potential impact on both innovative companies, facing potential threats to their market positions, and those dedicated to expanding access, where regulatory hurdles can dictate the economic viability of new products. Read the insightful analysis by Daniela and Guillermo in their latest publication on Lexology, where they dissect the ANVISA Public Consultation and its implications for the pharmaceutical industry: Link to the Article Stay informed, stay ahead. https://lnkd.in/dnCQj89z #BiologicalDrugs #RegulatoryInsights #PharmaceuticalIndustry #ANVISAUpdate
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Hi everyone! Dr. Cote is thrilled to share this week's Orphan Minute where he unravels the 3 key differences between the FDA and EMA orphan drug designations. Watch, learn, and let’s discuss how these regulatory nuances could impact your development strategies. Your thoughts and questions are welcome in the comments! #Pharma #Biotech #OrphanDrug #FDA #EMA #RegulatoryAffairs #DrugDevelopment
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World TB Day reminds us that through science, solidarity, and compassion, ending TB is not just a dream but a goal within reach. Society of Pharmaceutical Sciences and Research #WorldTBDay #spsr #societyofpharmaceuticalsciencesandresearch
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🆕 Exciting Update for Generic Drug Applicants! Recently, the USFDA released new guidance titled "Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA." This guidance is designed to support generic drug applicants in understanding the nuances of Product-Specific Guidance (PSG) teleconferences and meetings, a critical part of the GDUFA III framework. This initiative aligns with the FDA's Drug Competition Action Plan, which aims to increase access to safe, high-quality, and effective generic drugs, ensuring patients can access the medicines they need. 🔗 Learn more: https://lnkd.in/g6eyADyh 🔗 More on the Drug Competition Action Plan: https://lnkd.in/dM8f6ydU #Pharma #FDA #DrugRegulation #GenericDrugs #HealthcareInnovation
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🔍 New Insights on Drug Patents and Exclusivity! 🧬 The recent study from USPTO, conducted in collaboration with the FDA, sheds light on the intricate landscape of drug patents and exclusivities. This comprehensive analysis, initiated in response to Senator Thom Tillis's call for transparent data, maps the journey from New Drug Application (NDA) approval to the first generic launch. Key findings reveal: 📊 Market Exclusivity: The study identifies 3 to 16 years of market exclusivity for various drugs, highlighting the delicate balance between innovation and generic competition. 🔬 Innovation in Action: The analysis covers top drugs like IMBRUVICA, VENTOLIN HFA, and LIPITOR, showcasing how follow-on patents and new formulations contribute to ongoing innovation and patient care. 🛡️ Collaborative Efforts: This study underscores the Biden Administration's commitment to promoting affordable medicine while ensuring robust and reliable patent rights. Explore the full report to understand how these findings can inform future policy and research, benefiting innovators and patients. 👉[https://lnkd.in/edVDMAcx] #Pharmaceuticals #Patents #DrugDevelopment #HealthcareInnovation #FDA #USPTO #GenericDrugs
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Global Regulatory Submission Manager at Vertex Pharmaceuticals |Pharmacist | Global Regulatory Affairs
So honored to have been part of a team that represented Vertex Pharmaceuticals at the 2024 Drug Information Association’s Regulatory Submissions Forum in North Bethesda, MD. I got to network with members of the FDA and got updated on the most recent eCTD version 4.0. Our role is to meticulously submit scientific documents and information making it easier for the FDA to review data, approve this new drugs, and monitor drugs after they go on the market. #fdaregulations #DIA #drugdevelopment
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