Thefdalawblog.com

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 …

Actived: 4 days ago

URL: https://www.thefdalawblog.com/2023/06/cdrh-seeks-public-comment-on-how-to-increase-patient-access-to-at-home-use-medical-technologies/

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 …

Category: Health Go 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 …

Category: Health Go Health

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WebOn October 21, 2022, FDA published a draft guidance document titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and …

Category: Health Go Health

Memo: Public Health Security and Bioterrorism Preparedness …

WebHPM SUMMARY PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 Pertinent Highlights of the Act Provides for a drug, …

Category: Health Go Health

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 …

Category: Food Go Health

HP&M is Pleased to Welcome Suchira Ghosh to the Firm

WebAugust 20, 2019. Hyman, Phelps & McNamara P.C. (“HP&M”) is pleased to announce that Suchira Ghosh has joined the firm as Counsel. Suchira comes to HP&M with more than …

Category: Health Go Health

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 …

Category: Food Go Health

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 …

Category: Health Go Health

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 …

Category: Food Go Health

Senior FDA Official Dr. Julie Beitz Joins Hyman, Phelps

WebHyman, Phelps & McNamara, P.C. (“HP&M”), the largest FDA-dedicated law firm, is pleased to announce that Julie Beitz, M.D. has joined the firm as a Principal Drug …

Category: Health Go Health

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 …

Category: Health Go Health

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, …

Category: Health Go Health

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 …

Category: Health Go Health

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 …

Category: Health Go Health

South Korea Aims to Establish Biohealth Industry as Strategic …

WebRecent Posts. Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit March 25, 2024; Conference Notebook: …

Category: Health Go Health

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 …

Category: Health Go Health

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s …

WebRecent Posts. Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical …

Category: Medical Go Health