• where experts go to learn about FDA
  • Year: 2019

    • 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 …

    • Updated CLIA Waiver Guidances Lack Details in Original DraftJanuary 14th, 2019

      In the midst of the government shutdown and with its accompanying lull in new FDA documents, we thought it would be a good time to update our readers on some guidances that were issued late last year.  Two such notable draft guidances were the, “Select …

    • FDA Solicits Feedback on Grace Period Timing for GUDID SubmissionsJanuary 11th, 2019

      On December 18, 2018, FDA opened a docket for public comment regarding its intention to shorten the grace period for Global Unique Device Identification Database (GUDID) submissions from thirty days to seven days.  The grace period starts when Device Identified (DI) information is first entered …

    • A Pair of FDC Act-Related Convictions Upheld on Appeal in the Eighth and Eleventh CircuitsJanuary 10th, 2019

      In two unrelated cases, two U.S. Courts of Appeal affirmed FDC Act-related convictions earlier this week.  In United States v. Patino, the Eighth Circuit held that it was not an abuse of discretion to allow the government to introduce, in connection with a 2016 prosecution …

    • HP&M Releases 2018 Litigation BriefingJanuary 9th, 2019

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We …

    • Does the 510(k) Program Need Predicate Modernization?January 8th, 2019

      The 510(k) program is based on substantial equivalence.  A 510(k) submitter wishing to market a new device must establish that it is as safe and effective as a legally marketed device that has already received clearance.  The baseline comparison device is known as a “predicate …