- With Oral Argument in Important False Claims Act Case Fast Approaching, A Reminder of the High Stakes March 23, 2023
- HP&M Attorney Mark Tobolowsky Co-Authors Article in Human Gene Therapy Advocating for the Acceptance of Microdystrophin Expression in DMD Patients as a Surrogate Endpoint for Accelerated Approval March 19, 2023
- It’s All So Simple Now: The First Traditional Marketing Authorization for a Non-PCR Based Test to Detect SARS-CoV-2 March 17, 2023
- FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations March 16, 2023
- Ricardo Carvajal to Moderate Panel at FDLI’s Food and Dietary Supplement Safety and Regulation Conference March 16, 2023
- 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
HPM Announces New Director
May 1, 2007Hyman, Phelps & McNamara, P.C. is very pleased to announce that Jeffrey K. Shapiro has joined the firm as a director. Prior to joining the firm, Mr. Shapiro was a partner at Hogan & Hartson. Mr. Shapiro’s practice focuses primarily on assisting medical device and diagnostic manufacturers in complying with FDA regulatory requirements. Mr. Shapiro assists clients with obtaining premarket clearance or approval and compliance with postmarket requirements, such as labeling and advertising, the quality system regulation, adverse event reporting requirements, the regulation of in vitro diagnostic assays and analyte specific reagents, and responding to Form 483s and Warning Letters. He has extensive experience in FDA regulatory aspects of mergers and acquisitions, supplier contracts, and filings with the U.S. Securities and Exchange Commission. Mr. Shapiro frequently advises clients in combination product and product jurisdiction matters. For many years, he has assisted clients in addressing FDA’s evolving regulation of human and cellular based tissue products, along with state licensure requirements in that area. Mr. Shapiro is the co-editor of “Promotion of Biomedical Products,” a textbook on FDA’s regulation of promotion and advertising, and is also the co-author of the book, “Combination Products: How to Develop the Optimal Strategic Path for Approval.” He has authored numerous articles.
Search FDA Law Blog
Subscribe
Latest Tweets
Tweets by @fdalawblogAwards & Honors
- The Best
Lawyers in America
US News & World Report - Ranked in Chambers USA 2018
- With Oral Argument in Important False Claims Act Case Fast Approaching, A Reminder of the High Stakes March 23, 2023
- HP&M Attorney Mark Tobolowsky Co-Authors Article in Human Gene Therapy Advocating for the Acceptance of Microdystrophin Expression in DMD Patients as a Surrogate Endpoint for Accelerated Approval March 19, 2023
- It’s All So Simple Now: The First Traditional Marketing Authorization for a Non-PCR Based Test to Detect SARS-CoV-2 March 17, 2023
- FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations March 16, 2023
- Ricardo Carvajal to Moderate Panel at FDLI’s Food and Dietary Supplement Safety and Regulation Conference March 16, 2023
- 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