Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
Key Takeaways - The Federal Trade Commission (FTC), now under Republican leadership, has continued its scrutiny of Orange Book listings for device patents, signaling bipartisan concern over potential anti-competitive...more
As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable laboratory testing...more
In 1980, the British rock band, Genesis, released “Misunderstanding.” Forty-three years later, the Food and Drug Administration and a medical device company fell into a misunderstanding about a product’s regulatory...more
The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Many of us remember the television commercial where an older woman falls and cries out, “Help! I’ve fallen and I can’t get up.” This image and quote came to our mind when FDA recently issued a Warning Letter to a medical...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Considering the tight timeline for preparing responses to FDA compliance actions coupled with the agency’s expectation for timely implementation of corrective and preventive actions, the benefit of obtaining feedback through...more
The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more
Food/Dietary Supplements - FDA Issues Warning Letters to Companies Selling Cannabidiol-Containing Products – The FDA announced it issued warning letters to 15 companies “for illegally selling products containing cannabidiol...more
Food/Dietary Supplements - Deputy Commissioner for Policy, Legislation, and International Affairs Gives Remarks at the Food Allergy Summit – The deputy commissioner stated, “Today, allergies are a growing public health and...more
The Food and Drug Administration, channeling Kool & The Gang’s 1979 hit, “Too Hot,” issued a Warning Letter to a medical device company that marketed a sealed sterilization container for unlawful promotion. ...more
Food/Dietary Supplements - FDA Issues Report on Certain Dog Foods – The Food and Drug Administration (FDA) continues to investigate cases of dilated cardiomyopathy (DCM) in dogs consuming certain dog foods. ...more
Food/Dietary Supplements - FDA Releases Imported Food Safety Strategy – The FDA announced its imported food safety strategy. ...more
Food/Dietary Supplements - FDA Releases Findings in Romaine Lettuce E. Coli - Outbreak – The FDA announced the findings of its ongoing investigation into the E. coli outbreak from romaine lettuce originating in...more
Food/Dietary Supplements - Commissioner Gottlieb Announces Plan to Enhance Dietary Supplement Regulation – The FDA Commissioner Scott Gottlieb issued a press release outlining the FDA’s plan to modernize the regulation and...more
Last week Health and Human Services (HHS) released its Statement of Regulatory Priorities for Fiscal Year 2019. Several of the FY19 priorities include: (1) combatting the opioid crisis; (2) strengthening individual health...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance. Only 33...more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
Companies can’t sign quality agreements and then say “we’re done.” This message was brought home with a recent Warning Letter issued by the Food and Drug Administration to a pharmaceutical company for violating current good...more
The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH),...more