Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
On September 1, 2020, the Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA) held a joint webinar to discuss the jointly-issued Employee Health and Food Safety Checklist for Human and...more
FDA Enters New Phase Of FSVP Enforcement - The U.S. Food and Drug Administration (FDA) has entered a new phase of enforcement for the Foreign Supplier Verification Program (FSVP) regulation, the legally required due...more
On July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility inspections as a result...more
On March 18, 2020, the United States Food and Drug Administration (FDA) announced the suspension of all domestic routine surveillance facility inspections until further notice. FDA took this measure to protect the health and...more
The U.S. Food and Drug Administration (FDA) said Friday it plans to resume on-site inspections of FDA-regulated facilities and other associated activities the week of July 20, 2020. The agency had temporarily halted most...more
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time....more
Dr. Stephen M. Hahn, the Commissioner of Food and Drugs for the Food and Drug Administration (FDA) issued a statement on July 10, 2020, describing the agency’s intentions and approach to resuming domestic inspections in light...more
On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced that it will be restarting on-site prioritized domestic inspections, including food facilities, during the week of July 20 after pausing such inspections...more
When the COVID-19 pandemic struck the U.S., manufacturers regulated by the Food and Drug Administration (FDA) were afforded some relief from agency inspections, allowing time to focus on adapting to a new norm. Roughly four...more
On June 2, 2020, the Senate Committee on Finance hosted a full Committee hearing entitled “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process.” Witnesses represented the U.S. Food and...more
During the current COVID-19 pandemic, the United States food industry has done an admirable job keeping food on the table of Americans with few shortages or disruptions reported, thanks in part to federal regulators easing up...more
On 18 March 2020, in addition to a series of responses to combat the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) announced that it is temporarily postponing all domestic routine surveillance facility...more
Late yesterday, the U.S. Food and Drug Administration (FDA) announced that due to the COVID-19 pandemic the agency has temporarily postponed all domestic routine surveillance facility inspections. This announcement is not...more
As the novel coronavirus (COVID-19) crisis has continued to escalate, both the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) have taken additional action to provide industry, the...more
LEGISLATION, REGULATIONS & STANDARDS - Virginia Law Limiting Use of “Milk” Advances - Following a vote in the Virginia House Agriculture Subcommittee, the state’s House of Delegates will reportedly consider a bill that...more
LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more
LEGISLATION, REGULATIONS & STANDARDS - U.S. Lawmakers Urge FDA to Act on CBD - A group of U.S. lawmakers, led by Reps. Chellie Pingree (D-Maine) and James Comer (R-Ky.), have urged the U.S. Food and Drug Administration...more
LEGISLATION, REGULATIONS & STANDARDS - “Shame on you, Washington Post”: FSIS Criticizes Reporting on Pork Inspections - The U.S. Food and Drug Administration’s Food Safety and Inspection Service (FSIS) has issued a...more
FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand...more
As previously reported, the Food and Drug Administration (FDA) and the U.S Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) are operating under significantly reduced functions since funding for the...more
On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators during surveillance and pre-approval...more
The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule...more
The Food and Drug Administration (FDA) has released an Excel file that lists all general inspection citations included on every FDA Form 483 (Inspectional Observations) issued for almost the past ten years, from October 2008...more
Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more