- Ninth Circuit Allows Fraud-on-the-FDA Claim in FCA Whistleblower Suit Against Medtronic, But Affirms Dismissal of Off-Label Promotion Claim April 8, 2021
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FDA Firms Up Implementation Date for the Reportable Food Registry
June 29, 2009By Ricardo Carvajal –
FDA has announced public workshops on the Reportable Food Registry intended to “explain the purpose of the Registry, how it will work, and the responsibilities of persons required to submit a report regarding instances of reportable food to FDA through the Reportable Food electronic portal.” The public workshops will also address the role of public health officials in submitting instances of reportable food to the Registry. Previously, FDA issued and requested comment on a draft guidance titled “Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007” (see our prior posting here). At that time, the agency indicated that the Registry would be implemented on September 8, 2009. This latest announcement of the public workshops suggests that further delays in implementation of the Registry are unlikely, and that FDA intends to meet the September 8 implementation date. Have you incorporated the Registry requirements into your recall SOP’s and training program?
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- Ninth Circuit Allows Fraud-on-the-FDA Claim in FCA Whistleblower Suit Against Medtronic, But Affirms Dismissal of Off-Label Promotion Claim April 8, 2021
- BARDA’s Mask Innovation Challenge – “I don’t pop in peach” April 6, 2021
- Bills, Bills, Bills: Congress Advances Bills to Address Drug Competition April 2, 2021
- New Prescription Drug Price Transparency Law in Virginia April 1, 2021
- FDA Releases Examples of Real-World Evidence Used in Medical Device Decision Making March 31, 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