- A (Not So) New Avenue to Challenge Misleading Rx Promotion – NAD January 25, 2023
- Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans January 24, 2023
- FDORA Enacted; HP&M Issues Detailed Summary and Analysis January 23, 2023
- CMS Rolls up its Sleeves on Price Negotiations, Sets Agenda for 2026 Negotiated Prices January 19, 2023
- FDA and Health Canada eSTAR Pilot is Open and Accepting Participant Requests January 17, 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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- A (Not So) New Avenue to Challenge Misleading Rx Promotion – NAD January 25, 2023
- Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans January 24, 2023
- FDORA Enacted; HP&M Issues Detailed Summary and Analysis January 23, 2023
- CMS Rolls up its Sleeves on Price Negotiations, Sets Agenda for 2026 Negotiated Prices January 19, 2023
- FDA and Health Canada eSTAR Pilot is Open and Accepting Participant Requests January 17, 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