- Eleventh Circuit’s Decision is Not a Catalyst For Change February 1, 2023
- The Orphan Drug Act Almost Failed to Clear the Launch Pad Before Achieving so Much for Patients! January 31, 2023
- An FDA Inspector’s Knock Will More Likely Be Followed by FDA’s Enforcement Hammer January 30, 2023
- 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
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Declaring its intent to stand on the original complaint in FTC v. Shire ViroPharma, the FTC has appealed the District Court for the District of Delaware’s decision to dismiss the Commission’s unfair competition case against Shire without prejudice. We previously blogged about this case here, and here.
Although District Court dismissals without prejudice are typically not subject to immediate appeal, the FTC seeks appellate jurisdiction by declaring that it will not amend its original Complaint despite the District Court’s grant of leave to do just that. Rather, the FTC will risk abandoning its case in District Court in favor of seeking a review of the key legal issue by the Third Circuit. This speaks to the significance of the lower court’s ruling that the FTC had failed to meet its statutory burden in bringing the case – the Shire ruling has already been cited against the FTC in at least four other pending cases.
We will continue to follow this case as it develops.
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- Eleventh Circuit’s Decision is Not a Catalyst For Change February 1, 2023
- The Orphan Drug Act Almost Failed to Clear the Launch Pad Before Achieving so Much for Patients! January 31, 2023
- An FDA Inspector’s Knock Will More Likely Be Followed by FDA’s Enforcement Hammer January 30, 2023
- 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
- 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