• where experts go to learn about FDA
    • Key Insights from FDA’s Webinar on the Breakthrough Designation ProgramJanuary 31st, 2019

      FDA recently hosted a webinar on the final guidance regarding the Breakthrough Devices Program.  The Breakthrough Device Program is meant to speed access to new devices that treat or diagnose “life-threatening or irreversibly debilitating diseases or conditions.”  See our previous post for a more in-depth …

    • HP&M’s Anne Walsh to Present on Pharmacovigilance & Drug Safety IssuesJanuary 31st, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Anne Walsh will present at this year’s Pharmacovigilance & Drug Safety: Risk Management & Regulatory Compliance Conference, to be held in Arlington, VA on March 12-13, 2019.   The focus of her presentation is on post-market …

    • Commissioner Gottlieb and CBER Director Marks Deliver “State of Cell and Gene Therapy” Joint StatementJanuary 30th, 2019

      As we await our nation’s State of the Union address, FDA’s own Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks issued a joint statement providing a state of union of sorts on the development and regulation of cell and …

    • Petition to Bar Hydroponic Operations from Organic CertificationJanuary 29th, 2019

      The question of whether hydroponic operations are eligible for organic certification in the United States has been debated since 1995.  In most countries, such as Mexico and Canada, and regions, such as the EU, organic certification cannot be extended to crops not grown in soil.  …

    • FDLI to Sponsor Webinar on Patient Assistance ProgramsJanuary 28th, 2019

      Next Thursday, February 7, the Food and Drug Law Institute will conduct a webinar entitled, “Patient Assistance Programs, Recent Enforcement and Best Practices.”  The webinar will cover the various forms of patient assistance programs, the legal authorities that apply to them, recent enforcement actions, best …

    • Case Dismissed: Strike Two for PMRSJanuary 28th, 2019

      In one of the multiple lawsuits that Pharmaceutical Manufacturing Research Services (PMRS) has filed against the FDA related to the approval of abuse-deterrent opioids in the last few years, the Eastern District of Pennsylvania summarily rejected PMRS’s bid to keep abuse-deterrent opioid, RoxyBond, off the …

    • Updates to FDA’s Software Pre-Certification ProgramJanuary 25th, 2019

      On January 7, 2019, FDA released new documents related to its Software Pre-Certification (Pre-Cert) Program: Developing a Software Precertification Program: A Working Model (Working Model) Software Precertification Program: Regulatory Framework for Conducting the Pilot Program within Current Authorities (Regulatory Framework) Software Precertification Program: 2019 Test Plan (Test Plan) In …

    • FDA Issues Final Rule on Medical Device Classification ProceduresJanuary 24th, 2019

      On December 17, 2018, FDA published a final rule, Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures, to amend its regulations governing classification and reclassification of medical devices to align with the relevant portions of the Federal Food, Drug, …

    • Pharmaceutical Manufacturers Must Submit 340B Ceiling Prices Starting in the First Quarter of 2019January 23rd, 2019

      Beginning February 15, drug manufacturers will have a new price to report to the Federal government: 340B ceiling price.  Under Section 340B of the Public Health Service Act, a manufacturer of covered outpatient drugs, as a condition of having its drugs be eligible for federal …

    • CBI’s 4th Edition Drug Pricing Transparency CongressJanuary 23rd, 2019

      CBI is holding its Fourth Edition Drug Pricing Transparency Congress on March 25-26, 2019 in Philadelphia, Pennsylvania.  This program convenes stakeholders to discuss how the future of drug pricing transparency regulations will impact commercialization, reimbursement, pricing, and compliance practices.  Given the novelty and complexity of …

    • What Will FDA Do With All Those “Violative” Stem Cell Clinics Once Enforcement Discretion Tolls in November 2020?January 21st, 2019

      Enforcement discretion for stem cell facilities (and certain other HCT/P manufacturers) ends in November of 2020, and as FDA indicated in a recent press release, the agency is “discouraged” by the dearth of manufacturers wanting to interact with them during the enforcement discretion period. Back in …

    • M.C. Escher By Way of Generic Drug PricingJanuary 18th, 2019

      Though FDA does not have the legal authority to control or even directly address drug prices, Commissioner Gottlieb has certainly not shied away from the issue.  In fact, drug (and biologic) competition and accessibility is one of Dr. Gottlieb’s main efforts at the Agency (see …

    • AdvaMed Updates Code of EthicsJanuary 17th, 2019

      On January 9, 2019, the Advanced Medical Technology Association (AdvaMed) announced updates to its “Code of Ethics on Interactions with Health Care Professionals” (Code).  The Code was last updated in 2008; the newest updates will become effective on January 1, 2020. The Code includes new sections …

    • FDA is “Discouraged” by Dearth of HCT/P Manufacturers that have Reached Out to Agency During Enforcement Discretion PeriodJanuary 16th, 2019

      In November of 2017, FDA published its enforcement discretion policy regarding HCT/Ps that don’t meet all four criteria under 21 CFR 1271.10(a): To give manufacturers time to determine if they need to submit an IND or marketing application in light of this guidance and, if such …

    • Vermont Report Finds that the Costs of Prescription Drug Importation May Outweigh SavingsJanuary 15th, 2019

      As we previously reported, Vermont Governor Phil Scott signed a new law in May 2018 allowing for the wholesale importation of prescription drugs from Canada into Vermont.  Vermont’s Agency of Human Services (VAHS) recently issued a report containing the Agency’s preliminary design for a “Canadian …