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
In a recently published Request for Information (RFI), the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) seeks public comment on options to potentially streamline and reduce the...more
On July 2, the US Department of Agriculture (USDA) Animal and Health Inspection Service (APHIS) published a Request for Information (RFI) seeking public comment on the improvement of regulatory processes governing genetically...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On September 20, 2023, the Consumer Product Safety Commission (CPSC) issued a Federal Register Notice and Request for Information asking for public comment about the use and presence of per- and polyfluoroalkyl substances...more
THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more
The bipartisan leadership of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions released a formal Request for Information (RFI) to the public on July 27, 2023, to...more
13 Republican AGs wrote a letter to the FDA in response to its Request for Information regarding “In-Home Disposal Systems for Opioid Analgesics,” a proposed mail-back program for leftover opioid products....more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily...more
The U.S. Food and Drug Administration (FDA) published a request for information in the Federal Register in connection with labeling of foods made with cultured seafood cells. FDA will use the information received to decide...more
The U.S. Food and Drug Administration (FDA) is requesting public comment on the labeling of seafood products made using cell culture technology. FDA’s Request for Information (RFI) entitled, “Labeling of Foods Comprised of or...more
Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more
On June 14, 2019, the FDA published a Consumer Update entitled "What You Need to Know (And What We're Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD." In the Update,...more
This past Friday, the Office of Civil Rights within the U.S. Department of Health and Human Services published a formal Request for Information on Modifying HIPAA Rules to Improve Coordinated Care. The RFI’s publication...more
The U.S. Food and Drug Administration (FDA) recently issued a request for information seeking data and other information on the prevalence and severity of sesame allergies in the U.S. and the prevalence of sesame-containing...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Seeks Input on Plant-Based Milks - The U.S. Food and Drug Administration (FDA) has solicited public input on questions related to plant-based substitutes for dairy products...more
The Food and Drug Administration recently issued a request for information on the use of the names of dairy foods in the labeling of plant-based products. This action arose from the agency’s Nutrition Innovation Strategy, one...more
The Food and Drug Administration (“FDA” or “the agency”) recently issued a proposed rule that will ease the Freedom of Information Act (“FOIA”) request process for certain records within FDA’s possession. The proposed rule...more
On July 18, 2018, the federal Department of Health and Human Services (HHS) sent a proposed rule to the Office of Management and Budget (OMB) for review and clearance. While the substance of the proposed rule is not yet...more
Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted. • Many of the more dramatic proposals would require federal rulemaking or...more
TSCA/FIFRA - EPA Extends Comment Period For Draft Guidance For Pesticide Registrants On Notifications, Non-notifications, And Minor Formulation Amendments: On October 5, 2017, the U.S. Environmental Protection Agency (EPA)...more
On September 8, 2017, the Food and Drug Administration (“FDA”) became the latest in a line of federal departments and agencies to seek public input on approaches to modify regulations and reduce the burden on stakeholders....more
Since our March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred...more
In September 2016, the Food and Drug Administration (FDA) took a number of actions concerning the use of the term “Healthy” in the labeling of food products. The FDA published notice in the Federal Register on the use of the...more