FDA has finalized a guidance that lays out clinical pharmacology information that sponsors of investigational drugs conducting human radiolabeled mass balance studies should include in their premarket applications. While the agency made some changes based on industry feedback, the final guidance is mostly unchanged from the draft version. Ferdous Al-Faruque reports in Regulatory Focus 📝 📢 https://bit.ly/3Y5n7Oo
Regulatory Affairs Professionals Society (RAPS)
Non-profit Organizations
Rockville, MD 172,444 followers
Driving Regulatory Excellence
About us
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide.
- Website
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https://www.raps.org
External link for Regulatory Affairs Professionals Society (RAPS)
- Industry
- Non-profit Organizations
- Company size
- 51-200 employees
- Headquarters
- Rockville, MD
- Type
- Nonprofit
- Founded
- 1976
- Specialties
- regulatory profession, regulatory affairs, professional association, medical devices, pharmaceuticals, and biotechnology
Locations
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Primary
5635 Fishers Lane
Suite 400
Rockville, MD 20852, US
Employees at Regulatory Affairs Professionals Society (RAPS)
Updates
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Where is the regulatory workforce growing the most? The data in our Global Regulatory Affairs Workforce Report hints at an answer to that question and so much more. Get your free copy today: https://bit.ly/4d2i1Yl
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FDA announced the creation of a Rare Disease Innovation Hub to speed development of new treatments, integrate regulation of drugs and biologics, and engage patient advocacy communities. Emily Hayes reports in Regulatory Focus ✅ https://bit.ly/3WbfAuL
FDA unveils rare disease innovation hub, plans public meeting this fall
raps.org
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We're honored to present the 2024 RAPS Fellows! These regulatory professionals join the venerated ranks of the RAPS Fellows. Fellows serve as important advisors and mentors for strategic collaboration, implementation of special initiatives, and international development across the regulatory community. Learn more here: https://bit.ly/4bIDOSP
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China is the world‘s second-largest pharmaceutical market, attracting numerous international pharmaceutical companies seeking marketing authorization for their active pharmaceutical ingredients and finished products. In this article from the latest issue of RF Quarterly, Lixue Zhang, MS, RAC, explores the quality considerations for international generic pharmaceutical products launched in the Chinese market. She also covers the fundamental principles of developing regulatory specifications, focusing on the stringent standards set by the Chinese Pharmacopoeia for residual solvents, heavy metals, and ignition residue. RAPS members get exclusive access to this article: https://bit.ly/4c1WkGv
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The FDA has issued a draft guidance to spur the development of new treatments for pediatric ulcerative colitis and pediatric Crohn’s disease, two types of inflammatory bowel disease. The guidance addresses study population, study design, efficacy considerations, and safety assessments. The guidance does not address extraintestinal manifestations, stricturing or fistulizing disease, or treatment of long-term complications of pediatric UC or CD. Joanne Eglovitch reports for Regulatory Focus: https://bit.ly/3xQvumo
FDA guidance addresses developing treatments for pediatric IBD
raps.org
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We're hiring for three roles to bolster our books and journals teams to meet the professional development needs of those in the healthcare regulatory field! Know someone who might be interested? Here's where to send them 👉 https://bit.ly/4cSHxhy
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FDA on Tuesday finalized guidance for sponsors explaining how it assesses user fees for combination products and the different programs available to sponsors for requesting user fee waivers under the Prescription Drug User Fee Act and the Medical Device User Fee Amendments programs. Joanne Eglovitch reports in Regulatory Focus ✍️ 📣 https://bit.ly/3LxhfFW
FDA issues final guidance user fees for combination products
raps.org
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FDA's Center for Devices and Radiological Health on Monday announced it has elevated its communication office to a new “super office” as part of a move to increase its organizational agility and enable the center to meet its Medical Device User Fee Amendments V goals as well as its strategic priorities for 2022-2025. Joanne Eglovitch reports in Regulatory Focus 📣 https://bit.ly/3Wt5KWF
CDRH announces reorganization, new communication ‘super office'
raps.org
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The European Commission has published the finalized text of the Artificial Intelligence Act which establishes a legal framework to promote the uptake of “human centric and trustworthy” AI for medical devices, in vitro diagnostic devices and other products. The Act also sets harmonized rules for placing products on the market, and is the world’s first comprehensive AI law, according to the European Parliament. Joanne Eglovitch reports in Regulatory Focus ✍️ 📢 https://bit.ly/4f62GGZ
EU publishes regulation governing use of AI in medical devices and IVDs
raps.org