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On September 27, 2022, FDA announced the publication of a  final guidance  document entitled Clinical Decision Support Software, Guidance for Industry and Food and Drug Administration Staff (Final CDS Guidance), which focuses on clarifying the types of clinical decision support (CDS) software functions that are excluded from the definition of device by the criteria in section 520(o)(1)(E) of the Federal Food Drug and Cosmetic Act.

This final guidance document addresses industry comments made in response to FDA’s September 2019 draft guidance (Draft CDS Guidance). The Final CDS Guidance streamlines the Draft CDS Guidance by focusing the scope on CDS intended to be used by state licensed, registered, or certified health care professionals , rather than those also used by patients and caregivers, which were included in the scope of the Draft CDS Guidance.Continue Reading FDA Announces Final Guidance on Clinical Decision Support Software

On May 10, 2022, FDA published draft guidance entitled, “Benefit-Risk Considerations for Product Quality Assessments”, which describes the benefit-risk principles applied by FDA when conducting product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 such applications.

In the draft guidance, FDA reiterates its risk-based regulatory approach and applies it in the product quality assessment context.  Specifically, the draft guidance states that FDA continues to identify potential risks to product quality associated with the formulation, manufacturing process, and packaging components when conducting a product quality assessment as well as the proposed control strategy for mitigating those risks.Continue Reading FDA issues draft guidance for use in product quality assessments

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.

This final rule, which takes effect as of September 1, 2021, withdraws and replaces a final rule that FDA promulgated on January 9, 2017, but which never became effective due to an outcry concerning a problematic knowledge provision that was contrary to the statutory scheme of the FDCA and to physicians’ autonomy to use FDA-approved products in an off-label manner.

Prior to the 2021 final rule, FDA issued a proposed rule on September 23, 2020 that eliminated the 2017 rule’s knowledge provision and was much more aligned with FDCA intent and current FDA policy and practice.  FDA maintains, and we agree, that August 2021 final rule remains largely unchanged from the 2020 proposed language.

The following is a review of some important changes that FDA regulated entities should take note of as they develop and market FDA regulated products:Continue Reading FDA clarifies evidence and knowledge requirements in intended use final rule

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

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

On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s ramped up regulatory initiatives for drug compounders. These initiatives include: (1) publishing a report that provides a list of all the drugs that outsourcing facilities have compounded; (2) publishing a guide entitled “Outsourcing Facility Information,” which is a compilation of key