On May 10, 2022, FDA published draft guidance entitled, “Benefit-Risk Considerations for Product Quality Assessments”, which describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted for FDA’s review as part of original new drug applications (NDAs), original biologics license applications (BLAs), or supplements to … Continue Reading
The House Energy and Commerce Committee seems poised to make substantial changes to the Food and Drug Administration’s (“FDA’s”) Accelerated Approval Program. The committee’s Democratic chairman, Frank Pallone, Jr. (D-NJ) and Republican ranking member, Cathy McMorris Rodgers (R-WA) have proposed competing bills that were featured prominently in the Health Subcommittee’s legislative hearing on March 17, … Continue Reading
On October 5, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act. The final rule, which takes effect January 3, 2022, comes nearly three years after the FDA first proposed it and, notably, … Continue Reading
On July 1, 2021, the Department of Justice (DOJ) released a memorandum signed by Attorney General Merrick Garland regarding the issuance and use of guidance documents. Addressed to the heads of all DOJ components, the memorandum rescinds two previous DOJ memoranda and outlines the principles governing the DOJ’s revised approach in evaluating guidance documents. 2017 … Continue Reading
On August 2, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule amending existing regulations (21 C.F.R. § 201.128 and 21 CFR § 801.4) that describe the types of evidence relevant to determine a drug or device’s intended use under the Food, Drug and Cosmetic Act (“FDCA”). See 86 Fed. Reg. 41,384–85. … Continue Reading
The Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) have been fighting fraudulent and deceptive advertising of health care devices, household cleaners, nutrition supplements, and other health care products promising to protect or mitigate the effects of the virus for pandemic-wary consumers since March 2020. Despite these efforts, false and misleading marketing … Continue Reading
On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation.[1] Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel and function during a clinical trial. FDA recognizes this information as important because … Continue Reading
On June 17, the Food and Drug Administration (FDA) continued its efforts to mitigate COVID-19’s disrupting impact on clinical trials by issuing guidance on statistical considerations for changes to trial conduct (FDA previously relaxed restrictions on protocol modifications). As expected, public health measures designed to control COVID-19’s rapid emergence as a global pandemic—social distancing, travel … Continue Reading
The recently passed “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act) is sweeping legislation that will have widespread impact on companies in the health care and life sciences space. In addition to expanding coverage of COVID-19 testing and preventive services, the Act includes provisions to address health care workforce needs, eases restrictions surrounding telehealth … Continue Reading
The Food and Drug Administration (FDA) recently released new draft guidance documents to clarify its approach to regulating software as a medical device. The first draft guidance, Clinical and Patient Decision Support Software, addresses provision of the 21st Century Cures Act that exempts certain clinical decision support software from the definition of a medical device. The … Continue Reading
On June 8, 2017, the Energy and Commerce Committee voted unanimously to approve an amended version of HR 2430, the FDA Reauthorization Act (FDARA) of 2017. The bill would extend the FDA prescription drug, medical device, generic drug, and biosimilar biological product user fee programs, which are scheduled to expire at the end of September. … Continue Reading
President Trump has released his FY 2018 budget proposal, which the Administration dubs “A New Foundation for American Greatness.” The proposed budget – which received a generally chilly reception on Capitol Hill – offers a mixed bag for the health care industry. On the one hand, a document summarizing the Department of Health and Human … Continue Reading
The Senate voted May 9, 2017 to approve the nomination of Scott Gottlieb, MD, to serve as Commissioner of Food and Drugs, by a vote of a 57-42. Dr. Gottlieb was sworn in on May 11.… Continue Reading
As previously reported, President Obama has signed into law the 21st Century Cures Act (PL 114-255), which is intended to spur the discovery and availability of new medical treatments. Reed Smith has prepared a client alert summarizing the major drug, device, and biologic development and approval provisions contained in the Cures Act. The alert is … Continue Reading
The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have announced that they are making permanent their “Program for Parallel Review of Medical Devices,” which is now operating as a pilot program. The parallel review initiative allows concurrent FDA and CMS review of a medical device with the goal … Continue Reading
As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The meeting comes at a time where recent litigation has raised hot-button issues regarding the relationship between FDA, off-label use of drugs … Continue Reading
On September 30, 2016, President Obama signed into law S 1878, the Advancing Hope Act, which modifies the FDA’s priority review voucher program for rare pediatric diseases and extends the program through December 31, 2016. In addition, the House has approved a number of health policy bills, including the following: HR 954, the “CO-OP Consumer … Continue Reading
On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The hearing is intended to inform FDA’s “comprehensive review of its regulations and policies” pertaining to such communications. The FDA poses a number of specific questions … Continue Reading
The Senate Health, Education, Labor and Pensions (HELP) Committee has approved the last of its biomedical innovation bills that form its counterpart to the House 21st Century Cures Act. Together with the bills cleared by the HELP committee in February and March 2016, the panel has now passed 19 bipartisan medical innovation bills. The five … Continue Reading
On April 12, 2016, the House of Representatives gave final approval to S. 2512, which would add the Zika virus to the FDA Priority Review Voucher Program that encourages treatments for tropical diseases. The bill, which was passed by the full Senate on March 18, 2016, is now cleared for the President’s signature.… Continue Reading
The Senate Health, Education, Labor and Pensions (HELP) Committee approved seven bills this month that are intended to promote biomedical innovation, building on legislation approved by the panel in February. Specifically, on March 9, the Committee approved: S. 1878, the Advancing Hope Act of 2015 — to extend and expand an FDA priority review voucher … Continue Reading
The Senate Health, Education, Labor and Pensions (HELP) Committee has approved several bipartisan health policy bills, including health information technology (HIT) legislation and bills aimed at spurring biomedical innovation to complement the “House 21st Century Cures” initiative. Specifically, on February 9, 2016, the Committee approved:… Continue Reading
On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks. The draft guidance details the agency’s specific recommendations, which address monitoring, identifying and managing cybersecurity vulnerabilities in medical devices that are software, or contain software (including firmware) or programmable … Continue Reading
