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FDA’s Reportable Food Registry Moves One Step Closer to Reality
November 6, 2008By Ricardo Carvajal –
FDA recently published a notice of a proposed collection of information that solicits comments on the use of its new electronic system, called MedWatchPlus Portal, for the collection, submission, and processing of adverse event reports and other safety information for all FDA-regulated products. FDA intends to use the new system to meet the agency’s obligations under § 417(b) of the FDC Act – added by § 1005 of the FDA Amendments Act of 2007 ("FDAAA") – which requires that FDA establish a Reportable Food Registry and electronic portal by September 27, 2008. As we discussed more fully in our FDAAA summary, § 417(d) requires a responsible party to submit an instance of a reportable food to the electronic portal within 24 hours for possible inclusion in the registry. That reporting requirement went into effect on September 27. However, FDA previously acknowledged that it would not meet the September deadline for establishment of the electronic portal, and indicated that it was developing a system that was expected to be operational in Spring 2009. The agency appears to be on track to meet its target date. In the interim, FDA has instructed industry to continue reporting instances of food adulteration to the relevant FDA District office.
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- 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
- Reminder: HP&M Webinar on Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45 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