FDA to Hold Workshop on Generic Orally Inhaled and Nasal Drug Products

Because we spend such a significant amount of our time on the development of complex drug products (whether 505(j) or 505(b)(2) submissions), any workshop that includes discussion of new methods for characterizing and demonstrating equivalence tends to get our attention. CDER/OGD will be hosting Generic Orally Inhaled and Nasal Drug Products Workshop on January 9,…

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Commissioner Gottlieb Announces New Medical Device Initiatives for 2018

Advancing Policies to Promote Safe, Effective MedTech Innovation Posted on December 11, 2017 in FDA Voice by Scott Gottlieb, M.D.: “Early in the coming year, FDA’s Center for Devices and Radiological Health (CDRH) intends to advance several important new regulatory policy initiatives to further modernize the medical devices program and continue to foster new medtech innovation…” Cited were…

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RAPS Reports FDA Unveils Six-Part Toxicology Roadmap to Expand Predictive Capabilities

Regulatory Focus, Zachary Brennan, December 6, 2017: “The US Food and Drug Administration’s (FDA) Toxicology Working Group this week laid out a six-part roadmap to help the agency better evaluate new methodologies and technologies for their potential to expand FDA’s toxicology predictive capabilities and to potentially reduce the use of animal testing… The six-part framework…

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FDA Approves First Implanted Lens Adjustable Post-cataract Surgery to Improve Vision

Sometimes we include a story because it’s simply fascinating: November 22 – “The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better…

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FDA Issues Important New Guidances: Pre-ANDA and Controlled Correspondence

In October of this year, FDA issued guidance that for the first time formalized the Pre-ANDA Meeting for developers of complex generics. Entitled “Formal Meetings Between FDA and ANDA Applicants of Complex Products,” “This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit or an applicant that has…

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