…receipt of the last reports or other information, but can also be helpful to identify any gaps in the planned approach and to ensure the team is addressing all aspects…

…clarity to internal and external stakeholders, and reduce the time burden on both internal and external stakeholders.” Id. at 6. Per the Summary, the following are notable plans as the…

…notification. More novel LDTs will need to pursue de novo classification, which in many cases requires extensive clinical data to support authorization. Either way, FDA will need to review each…

…Here are some examples of recent meetings we have helped plan: EL-PFDD Meetings HPM Helped Plan and Moderated (Since November 2018) Disease Patient Organization Meeting Date Mitochondrial Diseases United Mitochondrial…

…case was framed as “whether the prior approval of a drug product, the active ingredient of which is a complex mixture of constituents, constitutes approval of each constituent as an…

…rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries. Part 1 can be submitted as much as 2 months (but no more…

…the level of a recall, e.g., market withdrawals. Almost all recalls are conducted on a voluntary basis by the manufacturer. FDA maintains a database for recalls of FDA-regulated products based…

…guidance document on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” Real-World Evidence: FDA plans to update the 2017 guidance document on “Use of Real-World Evidence to Support…

…May 10, 2016, FDA published the final “deeming regulation” asserting authority over all tobacco products meeting the broad statutory definition of a “tobacco product.” This authority extends to electronic nicotine…

The FSMA final rule on intentional adulteration, entitled “Mitigation Strategies to Protect Food against Intentional Adulteration” (IA rule), 21 C.F.R. Part 121, was published in May, 2016. The rule is…

…the Court already enjoined.”  Zogenix also alleged that the regulations violate the Contract Clause and the Commerce Clause of the U.S. Constitution, as well as the Equal Protection Clause “by…

…(URA) calculation, if that calculation produces a URA higher than that produced under the ordinary statutory methodology. The alternative calculation was intended to tie the URA of the line extension…

…chain, and all KDEs must be linked to the relevant TLC. All persons covered by the final rule must also establish and maintain a traceability plan that includes a description…

…structural/physicochemical and functional properties. Step 2: Rank these quality attributes according to risk of potential clinical impact. Step 3: Evaluate these attributes based on three tiers of statistical approaches. The…

…of establishing the study plan, protocol, and/or analysis plan relative to collection or retrieval of the RWD; the sources and technical methods used for data element capture (e.g., chart abstraction,…