- Getting Into the Weeds of USDA’s Hemp Production Program Regulations February 24, 2021
- “Tongue and Done” – Just . . . No. February 18, 2021
- ACI’s 36th FDA Boot Camp (Virtual Conference) February 9, 2021
- HP&M’s Food, Beverage & Supplement Wrap Up: January 2021 February 8, 2021
- ACI’s Advanced Legal, Regulatory, and Compliance Forum on OTC Drugs (Virtual Conference) February 4, 2021
- 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
FDA and Product Jurisdiction: Time for Reforms
March 1, 2016FDA regulatory requirements for products are heavily influenced by the product’s classification. FDA has developed procedures for determining whether a product should be regulated as a drug, device, or biologic. Understanding FDA’s procedures for determining jurisdiction is essential for companies that are seeking to market a product where it is not clear which category the product falls into or which Center will regulate it. Unfortunately, FDA’s own procedures for establishing jurisdiction are themselves not clear and can lead to unexpected outcomes. In a new article in FDLI’s Update Magazine, titled "FDA and Product Jurisdiction: Time for Reforms," Hyman, Phelps & McNamara, P.C., Director Jeffrey N. Gibbs discusses the FDA jurisdictional process and some of its challenges.
Reminder: Register now for the May 3, 2016 Virginia Tech and HP&M Conference on Effective Documentation. Information on the conference is available here.
Search FDA Law Blog
Subscribe
Enter your email address to automatically receive new posts to the FDA Law Blog via e-mail.
Latest Tweets
Tweets by @fdalawblogAwards & Honors
- The Best
Lawyers in America
US News & World Report - Ranked in Chambers USA 2018
- Getting Into the Weeds of USDA’s Hemp Production Program Regulations February 24, 2021
- “Tongue and Done” – Just . . . No. February 18, 2021
- ACI’s 36th FDA Boot Camp (Virtual Conference) February 9, 2021
- HP&M’s Food, Beverage & Supplement Wrap Up: January 2021 February 8, 2021
- ACI’s Advanced Legal, Regulatory, and Compliance Forum on OTC Drugs (Virtual Conference) February 4, 2021
- 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