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CDRH’s Plan to De-risk the Medical Device Valley of Death
WEBThe TAP Pilot is intended to “de-risk the medical device valley of death,” the metaphorical place where innovative technologies die while trying to reach the market. U.S. Food & Drug Admin., CDRH Launches the Total Product Life Cycle Advisory Program Pilot (Oct. 11, 2022) [hereinafter “ Announcement ”]. One cause of death in this
Actived: 5 days ago
URL: https://www.thefdalawblog.com/2022/11/cdrhs-plan-to-de-risk-the-medical-device-valley-of-death/
FDA Proposes Select Updates to the Breakthrough Devices …
WEBOn October 21, 2022, FDA published a draft guidance document titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care.. This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document.. FDA intends to …
CDRH Seeks Public Comment on How to Increase Patient Access …
WEBOn June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. According to the announcement, enabling patients to access medical devices beyond traditional clinical settings can help …
FDA Launches Digital Health Center of Excellence
WEBOn September 22, FDA announced the creation of a Digital Health Center of Excellence (DHCoE), which has grown out of their existing Digital Health Program. The objectives of the DHCoE include connecting and building partnerships, sharing knowledge and innovating regulatory approaches related to digital health.
New Breakthrough Devices Program Guidance: Expanding …
WEBOn September 15, 2023, FDA released a final guidance document titled “Breakthrough Devices Program.” Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities …
Be Still, My Beating Heart: FDA Announces Qualified Health Claims …
WEBChocolate-lovers and hopeless romantics rejoice: FDA has announced that it does not intend to object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease.. Though not quite a love letter, FDA’s letter to …
Changes to Existing Medical Software Policies Resulting from …
WEBNearly three years after Section 3060(a) of the 21st Century Cures Act amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by removing certain software functions from the device definition in section 201(h) of the FD&C Act, FDA has released Changes to Existing Medical Software Policies Resulting from …
FDA Creates a New Advisory Committee for Genetic Metabolic …
WEBOn December 12, 2023, FDA announced the creation of a new advisory committee specifically for treatments for genetic metabolic diseases, the Genetic Metabolic Diseases Advisory Committee, or “GeMDAC.” As described by FDA’s press release, genetic metabolic diseases are conditions whereby a genetic mutation, generally one that leads …
Food and Drug Omnibus Reform Act of 2022
WEBEXECUTIVE SUMMARY. On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023, Pub. L. No. 117-328 (2022).1 FDORA primarily amends the Federal Food, Drug, and Cosmetic Act (“FDC Act”) and the Public Health Service Act …
Corporate Liability from Employee Diversion: Costly on Many Fronts
WEBOn June 8, 2022, the U.S. Attorney’s Office for the Western District of Virginia, announced that Sovah Health (“Sovah”), a two-campus health system in Danville and Martinsville in southern Virginia, had entered into a non-prosecution agreement (“NPA”) and $4.36 million civil settlement due in large part to the ability of two employees to divert significant …
While we know that the Food and Drug Administration’s …
WEBDecember 5, 2023 President Joseph R. Biden, Jr. The White House 1600 Pennsylvania Avenue, N.W. Washington, D.C. 20500 Dear Mr. President, Thank you for your leadership in directing the Department of Health and Human Services (HHS)
Joint Basis for FDA/HHS Marijuana Rescheduling …
WEBJoint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled. In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act …
New Prescription Drug Price Transparency Law in Virginia
WEBOn March 24, 2021, Virginia became the latest state to enact a prescription drug price transparency law. Similar to other state drug price transparency laws (see, for example, our coverage here and here), HB 2007 sets forth reporting requirements applicable to health carriers, pharmacy benefit managers (PBMs), wholesale distributors, and manufacturers.
Senior FDA Official Dr. Julie Beitz Joins Hyman, Phelps
WEBRecent Posts. The End* of a Long and Winding Road: FDA Publishes Final LDT Rule (*Or Is It?) May 3, 2024; Sarah Wicks Returns to HPM to Elevate Drug Development and Regulatory Practice May 2, 2024; FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction May 1, 2024; Democratic …
Ding Dong is the Skinny Label (Effectively) Dead
WEBTeva decision, the skinny label may be dead. The “skinny label,” also known as a “carve-out” or a “section viii statement,” is a widely-used statutory provision adopted in the Hatch Waxman Amendments that allows generic sponsors to come to market notwithstanding a method-of-use patent covering an aspect of the reference listed drug
Up, Up and But Not Away: DEA Raises Registration Fees
WEBDEA concluded that calculating fees using this methodology is “not reasonable” as required by the CSA as the disparity among registrant would be “too great,” resulting in reduced fees for manufacturers and distributors by 90 percent and 80 percent, and increase practitioner fees by 23 percent. Fed. Reg. 44,722-23.
“TAP Dancing” Towards Faster Device Commercialization: CDRH’s …
WEBRecent Posts. The End* of a Long and Winding Road: FDA Publishes Final LDT Rule (*Or Is It?) May 3, 2024; Sarah Wicks Returns to HPM to Elevate Drug Development and Regulatory Practice May 2, 2024; FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction May 1, 2024; Democratic …
FDA End-of-Year Release of Warning Letters Impresses (or …
WEBPrimacy and recency are recognized psychological phenomena: people tend to remember the first thing they hear, and the last. It’s why litigators concentrate on their opening statement to a jury, and their closing argument. Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared …
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