- We Have an LDT Proposed Rule! September 29, 2023
- Fool Me Once, Shame on You. Fool Me Twice and It’s a Federal Felony—Always? September 29, 2023
- Clinical Trial Diversity: Understanding the Effects of the New Federal Guidelines on Your Clinical Trials September 29, 2023
- FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA September 28, 2023
- Hyman, Phelps & McNamara, P.C. Names Jeff Grizzel Chief Marketing Officer September 26, 2023
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HP&M Attorney to Moderate FDLI Webinar on FDA’s (Emerging) Oversight of Laboratory-Developed Tests
August 2, 2010On August 4, 2010, the Food and Drug Law Institute (“FDLI”) will host a webinar, titled “FDA’s (Emerging) Oversight of Laboratory-Developed Tests.” Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs will moderate the webinar and a panel of speakers that includes FDA’s Elizabeth A. Mansfield, Ph.D., who is Director of Personalized Medicine in the Office of In Vitro Diagnostic Device Evaluation and Safety in the Center for Devices and Radiological Health. Information about the webinar, including how to register, is available here.
As we recently reported, Laboratory-Developed Tests (“LDTs”) are a hot topic. In July, FDA held a workshop, during which Agency officials stated that FDA plans to regulate some LDTs as medical devices, ending the enforcement discretion FDA has historically exercised over some LDTs.
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- We Have an LDT Proposed Rule! September 29, 2023
- Fool Me Once, Shame on You. Fool Me Twice and It’s a Federal Felony—Always? September 29, 2023
- Clinical Trial Diversity: Understanding the Effects of the New Federal Guidelines on Your Clinical Trials September 29, 2023
- FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA September 28, 2023
- Hyman, Phelps & McNamara, P.C. Names Jeff Grizzel Chief Marketing Officer September 26, 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