- Conference Notebook: Reporting from FDLI’s 2023 Enforcement, Compliance, and Litigation Conference December 8, 2023
- HP&M Files Comments Opposing FDA’s Proposed LDT Rule December 7, 2023
- Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales December 5, 2023
- CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program December 4, 2023
- HPMers Slated to Speak at FDLI’s Enforcement, Litigation and Compliance Conference December 1, 2023
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Last month we reported that FDA decided to delay the compliance date for restaurant menu labeling from May 5, 2017 to May 7, 2018 while it reconsiders certain aspects of the final menu labeling rule. The Agency requested comments from industry and other stakeholder about how the rule should be revised to reduce the regulatory burden on restaurants and other covered establishments: FDA said that only comments submitted within 60 days (by July 3, 2017) would be considered. Now, FDA is adding 30 days to the comment period.
The extension comes in response to a request from the National Restaurant Association (NRA). About halfway into the original comment period, NRA told FDA that it would be “nearly impossible” to prepare and submit its comments without an additional 60-day extension. Yesterday, with the deadline right around the corner, FDA stated in a letter to NRA that the Agency will extend the comment period by 30 days. Although it isn’t the full 60-day extension that NRA requested, restaurants and other interested parties will now have (by our count) until August 2, 2017 to submit comments. An official announcement of the extension (in the Federal Register) is forthcoming. FDA’s decision does not change the May 7, 2018 compliance date.
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- Conference Notebook: Reporting from FDLI’s 2023 Enforcement, Compliance, and Litigation Conference December 8, 2023
- HP&M Files Comments Opposing FDA’s Proposed LDT Rule December 7, 2023
- Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales December 5, 2023
- CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program December 4, 2023
- HPMers Slated to Speak at FDLI’s Enforcement, Litigation and Compliance Conference December 1, 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