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Challenges of Implementing FSMA Import Provisions Take Shape
March 30, 2011By Ricardo Carvajal –
At FDA’s public meeting on the food import safety provisions of the Food Safety Modernization Act ("FSMA") (see our prior blog posting here), the challenges posed by implementation of those provisions started to take shape. Presentations by agency personnel, industry representatives, and consumer advocates highlighted the following issues (among many more):
◦ limited agency funding and personnel
◦ tight statutory deadlines
◦ ambiguous statutory terms
◦ integration of, or harmonization with, existing standards
◦ addressing reliability of third-party audits
◦ potential adverse effects on small and medium size businesses
◦ impact on competitiveness and efficiency
There was genuine enthusiasm for the possibility that certain aspects of the law, such as the Voluntary Qualified Importer Program, could help smooth the importation process for some importers. However, there was also concern that the Foreign Supplier Verification Program requirements could prove unduly burdensome for others. Much will depend on how the agency resolves perhaps the most fundamental issue of all – who qualifies as an importer?
You can read the Deputy Commissioner for Foods' take on the new paradigm for importers here.
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- Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act February 3, 2023
- 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
- 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