Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a specific drug or biological product, as combination products requiring clearance or approval from the agency prior to marketing.
FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall guideline at 21 CFR Part 7.
The Food and Drug Administration (FDA) may be closing in on solving one of its perennial regulatory problems, namely, the absence of a workable regulatory pathway for devices that seek to use older, mainly generic drugs in innovative ways.
Yesterday, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing Practice (GMP) violations observed during FDA’s July 2017 inspection of American CryoStem’s New Jersey facility. In a related press release, the agency cited the
Today, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development, review, and Emergency Use Authorization (EUA) for medical products that could help protect and treat U.S. military forces. The legislation was developed as an alternative to a provision in the National Defense Authorization
On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited programs available for the development and review of certain regenerative medicine therapies. Importantly, the draft guidance clarifies certain aspects of the Regenerative Medicine Advanced Therapy (RMAT) designation established by
Yesterday, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. This initiative builds on the agency’s existing framework to set forth more clearly which products are subject to regulatory enforcement. In September, as we previously discussed here and here, FDA’s Commissioner,
Earlier today, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of [pharmaceutical] manufacturing facilities that meet FDA requirements,” and that the Agency will begin relying “on the inspectional data obtained by these eight regulatory agencies” immediately.
Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment with an investigational product when there is no therapeutic alternative. In particular, FDA made three announcements: FDA has decided that physicians requesting individual patient
The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS), issued final joint guidance on maintaining meeting minutes for Institutional Review Boards (IRBs).
FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products. FDA Commissioner Scott Gottlieb, M.D. stated, “Tools like [FAERS] are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and
On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning letter issued to U.S. Stem Cell Clinic located in Sunrise, FL. FDA issued the warning letter following an inspection beginning in April
Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771, Reducing Regulatory and Controlling Regulatory Costs and Executive Order 13777, Enforcing the Regulatory Reform Agenda. On September 8, 2017, FDA published several notices in the Federal Register, to implement these orders, soliciting comments from the
On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for people at high risk of contracting the disease—that were discovered during an FDA inspection at StemImmune Inc., a San Diego, California company that purports to specialize
The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current confidentiality arrangements that apply to the cooperative law enforcement activities conducted by the regulators. The new confidentiality commitment allows the regulators to share
Yesterday, on August 21, 2017, FDA solicited comments in the Federal Register on a new potential approach regarding communicating risk information in direct-to-consumer (DTC) broadcast ads for prescription drugs and biologics that contain product claims. These types of ads must include, among other things, what is often called a “major statement,” i.e., information relating to the advertised drug’s “major side effects and contraindications” in either the audio or the audio and visual parts of the ad. 21 CFR 202.1(e)(1).
In the FR notice, the agency explained that it is considering a new approach to satisfy this requirement called a “limited risks plus disclosure strategy.” Under this approach, the major statement would be limited to 1) “severe (life-threatening), serious, or actionable” risks and 2) a disclosure to alert consumers that there are other risks not included in the ad. The Federal Register notice elaborated on the definitions of “serious” and “actionable” risks.
On July 25, 2017, FDA issued a guidance document implementing a policy which allows IRBs to waive general informed consent requirements for minimal risk studies, similar to the waivers allowed under the Common Rule.
FDA has announced public meetings and a pilot program related to the electronic exchange of tracking information for prescription drugs in the supply chain.
The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills seeking to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to clarify how drug and device manufacturers can legally discuss uses of
In a potential sign of renewed interest in financial ties between industry and clinical investigators, the Food and Drug Administration’s (FDA) Office of New Drugs (OND) recently issued a new Manual of Policies and Procedures (MAPP) outlining the Office’s policy goals, roles, and responsibilities with respect to financial disclosures in NDAs, BLAs and NDA/BLA supplements.
Continuous manufacturing has often been highlighted by FDA as an exciting technology in the area of pharmaceutical manufacturing, but one that the Agency is still wrapping its head around. Accordingly, on June 22, 2017, FDA announced the availability of a public docket (FDA-2017-N-2697) to collect comments and recommendations on the issue of continuous manufacturing. FDA
On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of reusable medical devices will now require the support of validated instructions for use and reprocessing instructions addressing cleaning, disinfection, and sterilization.
On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors should submit Form FDA 3674 certifications stating that they have complied with their obligations to submit required clinical trial information to clinicaltrials.gov.
On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device identifier (UDI) compliance date for certain class I devices which are subject to current Good Manufacturing Practice (cGMP) requirements and unclassified devices.