I will cherish my time as CDER’s Center Director. It has been the greatest honor and privilege of my professional life. I’d like to thank my colleagues for their commitment to protecting public health and the opportunity to engage with you.
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CDER Director
540 posts
CDER Director
@FDACDERDirector
Official Twitter account for the Director of FDA’s Center for Drug Evaluation and Research (CDER). Privacy Policy - https://t.co/gtX3WXfzSG
Silver Spring, MD Katılım Ekim 2020
47 Takip Edilen3.5K Takipçiler
As I retire from FDA today, I can say with confidence that CDER is at its strongest. We have hired & retained record numbers of the best scientists & professionals and created a culture that fosters respect, inclusion, accountability, & diversity of thought & life experience.
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I want to thank our review teams for their hard work and dedication for advancing patient care through timely and thorough review and approval of safe and effective therapies. We look forward to 2025 and the advances it will bring.
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The 2024 report includes approvals that collectively treat a wide range of conditions, including 26 new therapies that had previously received an orphan drug designation to prevent, diagnose or treat a rare disease or condition and a major milestone with the 60th biosimilar.
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This new FDA Voices article, along with the New Drug Therapy Approvals report, features drug approvals that CDER considers likely to have a significant impact on public health & improve the lives of the patients and consumers that will use them: fda.gov/news-events/fd…
FDA Drug Information@FDA_Drug_Info
CDER published its report on new drug approvals in 2024, Advancing Health Through Innovation: New Drug Therapy Approvals. This report features notable approvals of drugs for new and expanded uses, novel approvals, new formulations, and new dosage forms: fda.gov/drugs/novel-dr…
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As 2024 concludes, I want to extend a heartfelt thank you to CDER staff for your continued service and dedication to our public health mission, and to the nation for your trust and support.
Wishing everyone a safe and joyful holiday season!
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The FDA encourages applicants to meet with the agency to discuss any questions that arise during the development of a nonprescription drug product with an ACNU.
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The pathway for nonprescription drugs with an ACNU could improve public health by broadening the types of nonprescription drugs available to consumers.
FDA Drug Information@FDA_Drug_Info
Today, FDA issued a final rule establishing requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU): fda.gov/drugs/drug-saf…
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CCRI represents a major step forward to unlock the potential of RWD to inform clinical & regulatory decisions. We are creating a focal point within CDER to identify ways we can utilize RWE to streamline the development of effective & safe medicines for conditions with unmet need.
FDA Drug Information@FDA_Drug_Info
Today, CDER announced the new Center for Real-World Evidence Innovation (CCRI) which aims to coordinate, advance, and promote the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making: fda.gov/drugs/drug-saf…
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As with several other user fee programs, FDA engages in negotiations with industry to develop recommendations to reauthorize OMUFA II. FDA will host a second and final public meeting tomorrow and we invite public comment on the OMUFA reauthorization recommendations.
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OTC monograph reform has benefitted patients, industry, and our nation’s health care system and has reduced regulatory burden. During the first years of the program, FDA has successfully created much of the infrastructure necessary to achieve these benefits.
FDA Drug Information@FDA_Drug_Info
In the latest From Our Perspective, learn about the OTC Monograph Drug User Fee Program (OMUFA) and how OTC monograph reform has helped increase efficiency, timeliness, and predictability of OTC monograph drug regulation, and streamlined safety updates: fda.gov/drugs/our-pers…
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Since 2015, 60+ biosimilars have received FDA approval, saving healthcare systems over $36 billion, and improving access to life-changing, quality medicines. These resources can help facilitate conversations between HCPs and patients who can benefit from these treatment options.
FDA Drug Information@FDA_Drug_Info
#Biosimilars meet the same quality standards as their FDA-approved reference products, biologics. FDA and @USPharmacopeia released an educational resource for providers to help patients better understand these treatment options: fda.gov/media/161628/d… #GlobalBiosimilarWeek
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It is FDA’s role to ensure that drugs are safe and effective. Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step to propose removing oral phenylephrine because it is not effective as a nasal decongestant.
FDA Drug Information@FDA_Drug_Info
FDA is proposing to remove oral phenylephrine as an active ingredient that can be used in OTC monograph drug products for the temporary relief of nasal congestion after review of the available data determined that it is not effective for this use: fda.gov/news-events/pr…
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Thank you to @RareDiseases for inviting me to speak at the Rare Diseases and Orphan Products Breakthrough Summit to contribute to critical discussions facing the rare disease community and to discuss clinical trial innovation. nordsummit.org
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The program continues to inspire by driving change through empathy, intelligence, and passion. I am proud of the significant initiatives we have undertaken and look forward to what we all can accomplish together in advancing therapies that will benefit the rare disease community.
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Building on its successful launch in 2022, the ARC Program has supported various activities to advance rare disease drug development. Over the past year, achievements included 29 rare disease new drug approvals, 40+ speaking engagements, patient-focused meetings, & more.
FDA Drug Information@FDA_Drug_Info
FDA released the 2024 Accelerating Rare disease Cures (ARC) Program Annual Report. It highlights accomplishments and dedication in driving scientific and regulatory innovation while addressing the challenges of developing drugs for rare diseases: fda.gov/media/182662/d…
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I look forward to providing the keynote address at the upcoming Annual Sentinel Initiative Workshop in November. Join the discussion with scientists, industry partners, and patients to promote engagement and collaboration within the public health community.
FDA Drug Information@FDA_Drug_Info
📣Join FDA and @DukeMargolis on Nov. 7th for FDA's 16th Annual Sentinel Initiative Workshop to learn about recent achievements & developments within the Sentinel Initiative. Hear from FDA, Sentinel leadership, & keynote from @FDACDERDirector. Register➡sentinelinitiative.org/news-events/me…
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The continued rise in availability of generics includes 956 approved or tentatively approved generic drug applications last year. As products become more complex, FDA will continue to provide information to generic drug developers and keep building on this historic success.
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There are many accomplishments to celebrate over the last 40 years since the Hatch-Waxman Amendments were enacted. In 1984, generic drugs accounted for only 19% of all prescription drug purchases in the U.S. while today, they account for more than 90%.
FDA Drug Information@FDA_Drug_Info
Today marks the 40th anniversary of the Hatch-Waxman Amendments, which established the approval pathway for generic drug products and the foundation for FDA’s Office of Generic Drugs: fda.gov/drugs/types-ap…
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Harnessing the power of these tools is critical for FDA’s mission to support innovation that improves patient access to safe and effective treatments.
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I look forward to speaking at the 2024 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop on 9/26 to discuss the intersection of statistics, data science, and AI in drug development.
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