The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products. The guidance finalizes an April 2019 draft that advised how firms in a distribution chain can prepare when conducting a voluntary recall. The guidance includes nonbinding recommendations and explicitly does not establish legally enforceable … Continue Reading
The United States recently passed the “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act), sweeping legislation that could impact pharmaceutical and medical device companies with U.S. operations or significant U.S. sales. A team of Reed Smith life sciences and health care lawyers, including Scot T. Hasselman, Robert J. Hill, Carol Colborn Loepere, Kevin M. Madagan, Paul W. Pitts, James … Continue Reading
Please join us for the next edition of Reed Smith’s FDA webinar series, “CBD: What now?”, on Wednesday, October 30, 2019 at 12:00 PM ET. Cori Goldberg, Marc Hauser, and Adam Brownrout will offer a summary of current federal (FDA, USDA) and state regulations for CBD and CBD products, and what they mean for businesses. … Continue Reading
On December 8, 2017 – nearly a year after President Obama signed into law the 21st Century Cures Act (“Cures Act”) – the Food and Drug Administration (“FDA”) released two new draft guidances that aim to implement section 3060 of the Cures Act, and provide clarity on the Agency’s regulatory approach to software as a … Continue Reading
The U.S. Food & Drug Administration (“FDA”) announced on November 7, 2017, that it is withdrawing the draft Guidance for Industry #230, “Compounding Animal Drugs from Bulk Drug Substances.” FDA confirmed that it does not intend to finalize the current draft. Rather, it will issue a new draft in early 2018 for public comment. For … Continue Reading
Washington D.C. Partner Kevin Madagan of Reed Smith’s Life Science Health Industry group will participate in an exert legal panel discussion at the 2017 Health Care Distribution Alliance (HDA) Traceability Seminar held November 8-10 in Washington D.C. Implementation of the Drug Supply Chain Security Act (DSCSA) continues to transform the pharmaceutical supply chain. As the … Continue Reading
On October 25, 2017, FDA released a critical draft guidance on the breakthrough medical device pathway established by the 21st Century Cures Act (the “Cures Act”). The Draft Guidance For Industry, Breakthrough Device Pathway (“Draft Guidance”) reflects FDA’s proposal regarding the process by which a sponsor may seek a designation as a breakthrough device, assigning … Continue Reading
Reed Smith’s Life Sciences Health Industry Group will be hosting an upcoming CLE webinar, “Hosting and Managing User Generated Content (UGC)” on Thursday, January 19, 2017 at 12 p.m. ET. This webinar will address the legal liability and responsibility of a drug or device company that incorporating any user generated content (UGC) features on websites … Continue Reading
Upcoming changes to Google AdWords’ ad formats will have a significant impact on pharmaceutical companies that engage in paid search advertising. In a letter to its major media agencies last month, Google announced that it will be removing two of its popular pharmaceutical advertising units. Black Box Ad Format On July 20, 2015, Google’s Black … Continue Reading
Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses. We provided links to amicus briefs by the Pharmaceutical Research and Manufacturers of America and the Washington … Continue Reading
As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses. As we noted, on June 8, 2015, … Continue Reading
The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices. In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do not circumvent the drug- and device-approval processes. … Continue Reading
On November 14, 2011, the Senate Health, Education, Labor and Pensions Committee held a hearing called "Medical Devices: Protecting Patients and Promoting Innovation." The hearing focused on the continued viability of a medical device clearance process that clears for market medical devices that are "substantially equivalent" devices to previously cleared devices (also known as the "510(k) process," in reference to the statutory provision governing this process). Class III medical devices not cleared through this process must undergo the more rigorous and time-consuming Premarket Approval process. Among the issues considered were whether the 510(k) process sufficiently evaluated the safety of devices when clinical data is not necessarily always considered or part of the submission; whether high-risk medical devices should always be considered for the 510(k) process; the user fees for medical device applications; strengthening post-approval monitoring requirements; and the resources and needs for the FDA and the Center of Devices and Radiological Health (CDRH) in reviewing, clearing and approving medical devices.… Continue Reading
On February 15, 2011, the Food and Drug Administration ("FDA") published a final rule reclassifying Medical Device Data Systems ("MDDS") as Class I medical devices exempt from 510(k) premarket notification requirements. FDA defined MDDS as medical devices that are intended to transfer, store, convert from one format to another according to preset specifications, or display "medical device data." FDA explicitly excluded electronic health record ("EHR") and computerized physician order entry ("CPOE") systems from the MDDS Final Rule. Because MDDS do not "provide new or unique algorithms or functions," FDA concluded that general controls, such as the Quality System Regulations are sufficient to mitigate any risks associated with MDDS.… Continue Reading
On January 19, 2011, FDA announced its long-awaited plans for revising the premarket notification (510(k)) process for medical devices to address the concerns that have been raised about the process by industry, consumers and Center for Devices and Radiological Health (CDRH) staff regarding the lack of predictability, consistency, transparency of the process, the inadequacy of the process to ensure the safety and effectiveness of products, and the lack of flexibility of the process to address changing technology and complexity. In 2009, CDRH established working groups to address these concerns. In August 2010, these working groups issued recommendations, which FDA analyzed and addressed as part of the announcement. FDA also sought public input and comments.… Continue Reading
FDA has issued a press release on its plan to reform the 510(k) medical device review process, outlining changes it intends to implement during 2011 including streamlining the "de novo" review process for certain innovative, lower-risk medical devices; clarifying when clinical data should be submitted in a premarket submission; and "establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making." Undoubtedly there will be much more on this in the coming weeks and months.… Continue Reading
Today the FDA published a notice announcing public hearings on November 2 and 3, 2010 on implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was enacted as part of the Affordable Care Act (ACA). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be … Continue Reading
Areta Kupchyk opines about possible picks for the FDA Commissioner in today’s Law360 article, “Obama’s FDA Commissioner Pick Could Be Outsider.”… Continue Reading
