TabsetOverviewBar & Court AdmissionsBar Admissions: MarylandEducation: University of Maryland School of LawJDHealth Law Concentration2009 University of MarylandBSPhysiology & Neurobiology2004 PaulS.GadiockSenior AttorneyWashington, DC 202.715.8542 paul.gadiock@arentfox.com Download vCard Paul provides premarket and postmarket regulatory solutions on a variety of subject matters for medical product clients. As a former policy director at FDA and business development leader at a national biotechnology company, Paul brings unique first-hand experience with the development and application of regulatory programs to counsel clients at all stages of the medical product life cycle. Paul's practice primarily focuses on helping medical device and biologics companies intelligently navigate local and national regulatory requirements. *Not admitted in the District of Columbia. Admitted in Maryland only. Practicing under supervision of Firm principals. Client WorkPaul advises small and large companies on a broad range of legal and regulatory issues, including: Determining regulatory requirements and least burdensome pathways for a mobile app developer to efficiently bring a device to market. Generating business-specific SOPs that comply with Quality System Regulations to promote business agility. Reviewing advertising material to ensure compliance with regulations while continuing to effectively promote capabilities to meet business needs. Creating comprehensive proposals aimed at influencing regulatory policy of specific medical products to decrease burden. Advising on relevant UDI requirements to fulfill high-visibility industry obligations and manage regulatory risk. Contacting client competitors to raise objections with company conduct and maintain competitive advantage. Determining and documenting the applicability of section 361 to biologic products. Conducting due diligence reviews to inform clients of risk when considering transactions. Previous WorkImmediately prior to joining Arent Fox, Paul served as the Associate Center Director for Policy in the FDA’s Center for Devices and Radiological Health where he advised key agency officials on issues related to the application of policies, programs, regulations, and legislation. He was instrumental in appropriately encompassing or excluding devices from the scope of medical product regulation. Paul also minimized legal risk in investigations, major national programs, as well as specific matters involving petitions and appeals to the FDA. He conducted numerous presentations and trained staff on how to streamline complex processes to reduce costs. Before his senior leadership role within FDA, Paul served as a Business Development Executive for a national diagnostic biotechnology company. He advised international directors on how the company could comply efficiently, leading to cost-effective development of products that could be marketed in multiple countries with different regulatory requirements. Paul united scientists and sales teams to enhance the company’s image and visibility by launching aggressive marketing campaigns. Publications, Presentations, and RecognitionsPaul's recent presentations include: "An In-Depth Dive into the Use of 3D Printing for Medical Technology," American Conference Institute Legal, Regulatory and Business Conference on 3D Printing; June 15, 2018 (Chicago, IL) "Center Director Breakout Sessions: CDRH," Food and Drug Law Institute; May 3-4, 2018 (Washington, DC) "Legal Perspective: Risk-Based Approaches to Contracting & Supplier Quality Agreements," Q1 Productions Semi-Annual Risk Based Medical Device Supplier Quality Assurance Conference; April 24, 2018 (Arlington, VA) "Regulation of Biological Marketing," Food & Drug Law Institute Introduction to US Biologics and Biosimilars Law and Regulation; March 21, 2018 (Washington, DC) "The CDRH Reorganization: Managing Total Product Life Cycle, Real World Evidence, and Digital Health Policies," FDANews; February 14, 2018 (Webinar) "LDTs: Limited Detection Test or Ludicrous Delay of Technology?" Food & Drug Law Institute Annual Conference; May 5, 2017 (Washington, DC) "Promotion and Advertising," Food & Drug Law Institute Introduction to US Medical Device Law and Regulation; April 27, 2017 (Washington, DC) "Recent FDA Guidance Documents on Manufacturer Communications about Medical Products," Food & Drug Law Institute; March 16, 2017 (Webinar) "351 vs 361 Products," 13th Annual FDA and the Changing Paradigm for HCT/P Regulation Conference; February 15, 2017 (Alexandria, VA) "Trump's First 100 Days, Part IV: AMCs, Life Sciences, Pharma, and Medical Device Companies," American Health Lawyers Association; February 10, 2017 (Webinar) "Medical Device Hot Topics for 2017," New York State Bar Association Food, Drug and Cosmetic Law Section Annual Meeting; January 26, 2017 (New York, NY) Paul's recent publications include: "Capturing Postmarket Benefits in Device Compliance and Enforcement," Food & Drug Law Institute’s FDLI Update, December 2017 "23andMe Green Light is a Shift for FDA," Daily Journal; April 28, 2017 "How Will Real World Evidence Affect Off-Label Communications and FDA?" Bloomberg Law Medical Devices Law & Industry Report; April 26, 2017 Newsroom Date Type Title 6 / 13 / 2018 Event Not stickyPaul Gadiock to Speak at the ACI’s Inaugural Legal, Regulatory and Business Conference on 3D Printing 5 / 3 / 2018 Event Not stickyPaul Gadiock and Emily Leongini to Moderate and Speak at the FDLI Annual Conference 4 / 23 / 2018 Event Not stickyPaul Gadiock to Speak at Risk Based Medical Device Supplier Quality Assurance Conference 4 / 17 / 2018 Alert Not stickyFDA Proposes New Class II Device Marketing Pathway 3 / 27 / 2018 Alert Not stickyCatching Fire: Plaintiffs Expand Proposition 65 Cannabis Targets and File Lawsuits 3 / 20 / 2018 Event Not stickyPaul Gadiock to Speak at the FDLI Introduction to US Biologics and Biosimilars Training Course 3 / 15 / 2018 Alert Not stickyIn Rare Move, FDA Debars Company from Importing Food 3 / 14 / 2018 Alert Not stickyFDA Authorizes First Direct-to-Consumer Genetic Test for Cancer 2 / 14 / 2018 Event Not stickyPaul Gadiock to Present FDANews Webinar on CDRH Reorganization 1 / 25 / 2018 Alert Not stickyNow Trending: Watchdog Groups Unleash New Wave of Proposition 65 Lawsuits Targeting Cannabis Dispensaries 1 / 23 / 2018 Alert Not stickyMedical Device Manufacturers Afforded Temporary Tax Relief 12 / 13 / 2017 Alert Not stickyRare Pediatric Disease Clinical Trials Get New Lift from EMA-Inspired Gaucher Model 12 / 5 / 2017 Media Mention (News) Not stickyJamie Ravitz and Paul Gadiock Co-Author Postmarket Benefits Article for FDLI Update Magazine 11 / 21 / 2017 Alert Not stickyFDA Issues Comprehensive Tissue Product Regulatory Framework 9 / 7 / 2017 Alert Not stickyFDA Trip Leads to Securities Stumble: The Gravity of Regulatory Due Diligence 8 / 9 / 2017 Alert Not stickyFDA and Duke University to Explore Expanded Use of Real-World Evidence for Drugs in Public Workshop 6 / 20 / 2017 Alert Not stickyFDA Announces Innovation Plan to Reboot Digital Health Device Regulation 5 / 26 / 2017 Alert Not stickyHow FDA’s Program Alignment Initiative Will Impact Industries: An Insider’s Perspective 4 / 4 / 2017 Alert Not stickyMobile Health Oops! New York Takes Action While Federal Regulators Falter 3 / 16 / 2017 Event Not stickyPaul Gadiock to Present a FDLI Webinar on Off-Label Communications 3 / 8 / 2017 Press Release Not stickyArent Fox Expands Food Safety Counseling with Addition of Former USDA Official 2 / 10 / 2017 Event Not stickyPaul Gadiock Presents AHLA Webinar on Trump’s First 100 Days 2 / 10 / 2017 Alert Not stickyTrump’s 2-for-1 Executive Order, its Impact on FDA, and the Significance of “Significant” 1 / 26 / 2017 Press Release Not stickyArent Fox Expands FDA Practice with Addition of Two Former Agency Officials Practice Area Leadership:
