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Richard Lewis Joins HP&M as Senior Regulatory Device & Biologics Expert
February 12, 2020Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Richard Lewis has become its newest Senior Regulatory Device & Biologics Expert. Coming to us after more than 4 years at FDA, Richard worked in the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) in both pre-market and compliance roles.
As a one of HP&M’s regulatory experts, Richard is using the training and experience gained at FDA as a pre-market reviewer to provide regulatory advice for medical devices, diagnostics, biological products, and human cellular and tissue-based products (HCT/Ps). In the post-market compliance space, Richard uses his GMP and inspection training and experience to assist clients in the handling of complaints, MDRs, Recalls, cGMP Compliance, Inspections, and Warning Letters.
Prior to joining FDA, Richard was a chemistry researcher in academia for eight years. He received his Ph.D. in Inorganic Chemistry at UC Santa Barbara and continued his training during a post-doctoral appointment at Yale University.
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- Hospitals: Do You Know Where Your Controlled Substances Are? May 16, 2024
- Join Us for an HPM/Lighthouse Labs Webinar: What the FDA’s Final Rule Means for the Future of Laboratory Developed Tests; Thursday, May 16, 2024: 12:00-1:00 PM EDT May 15, 2024
- When Worlds Collide: The Theory of Real-World Evidence Meets Reality May 14, 2024
- Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices May 7, 2024
- DEA Concurs: Marijuana Meets Schedule III Criteria May 6, 2024
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized