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Court Rejects FDA’s “Target Timeframes” for FSMA Regulations and Orders Publication by June 30, 2015
June 30, 2013By Ricardo Carvajal –
A federal district court rejected FDA’s proposed “target timeframes” for issuance of regulations to implement major provisions of the Food Safety Modernization Act ("FSMA"), finding them to be “an inadequate response to the request that the parties submit a proposal regarding deadlines that can form the basis of an injunction.” For a summary of prior activity in this case, see here). However, the court also rejected Plaintiffs’ proposed deadlines as “overly restrictive in light of FDA’s showing of the complexity of the task… and its showing of diligence in attempting to discharge its statutory duty to promulgate regulations.” Further, the court rejected Plaintiffs’ plea to eliminate OMB review “absent some indication that the OMB is using its authority to unduly delay promulgation of the regulations.”
Recognizing the need for an adequate comment period and OMB review, the court ordered that proposed regulations not yet published in the Federal Register be published by November 30, 2013, with all comment periods closing by March 31 2014. Final regulations must publish in the Federal Register by June 30, 2015. In essence, these publication dates show deference to FDA’s “target timeframes” – an indication of the court’s reluctance to take too strong a hand in driving FSMA implementation.
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- Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling April 23, 2024
- “Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application . . . And a Corrected NDA Approval Letter is No Saving Grace April 22, 2024
- Clear that Cabinet Tour ‘24 April 18, 2024
- The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation” April 17, 2024
- Does the Drug Shortage White Paper Fall Short? April 9, 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