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New Schedule Set for Issuance of FSMA Rules
February 21, 2014By Ricardo Carvajal –
FDA entered into a consent decree with the Center for Food Safety that specifies new deadlines for the agency’s submission of final rules implementing FSMA to the Federal Register for publication. The consent decree marks the latest chapter in a case that started in August 2012 and wound its way to the 9th Circuit amid last year’s partial government shutdown. The new deadlines corresponding to each rule are listed below:
August 30, 2015
- Preventive Controls for Human Food (FSMA Section 103(a) and 103(c))
- Preventive Controls for Animal Food (FSMA Section 103(a) and 103(c))
October 31, 2015
- Foreign Supplier Verification Program (FSMA Section 301(a))
- Produce Safety Standards (FSMA Section 105(a))
- Accreditation of Third Party Auditors (FSMA Section 307)
March 31, 2016
- Sanitary Transport of Food and Feed (FSMA Section 111)
May 31, 2016
- Intentional Contamination (FSMA Section 106(b))
Under the terms of the decree, FDA agrees “in good faith” to “make every effort” to meet the above deadlines. However, the deadlines can be extended by mutual agreement between the parties, or through modification by the court based upon a request by FDA that must “show good cause and/or exceptional circumstances warranting the delay, and address the effect of the delay on the public health and safety, among other relevant considerations.”
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- Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3 . . . and PART 3½) March 14, 2024
- Drugs Companies Clap Back at Congress…Then Get Sued March 13, 2024
- Bad Labs! Bad Labs? Whatcha Gonna Do? March 12, 2024
- 15 Years Strong: Rare Disease Week’s Remarkable Journey of Support March 10, 2024
- HP&M’s Larry Houck A Panelist at FDLI’s Cannabis Regulation Conference March 10, 2024
- 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