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FDA Extends Deadline for Reporting Samples Under ACA
March 30, 2012By Alan M. Kirschenbaum –
Two days ago, during argument before the Supreme Court on the Affordable Care Act ("ACA"), Justice Breyer referred to “loads” of miscellaneous provisions of the Act outside the core insurance provisions. One of these is section 6004, which requires manufacturers and authorized distributors of record to submit information on drug samples to FDA annually beginning April 1, 2012 (this Sunday). Today, FDA issued a brief draft guidance announcing that FDA will exercise its enforcement discretion to extend the deadline for reporting until at least October 1, 2012. The guidance states that FDA will provide notice before revising this policy, indicating the possibly of a further extension. By then, we will know whether this and “loads” of other ACA provisions will survive the Supreme Court’s decision, expected in June. If and when required, the sample information will be submitted electronically through FDA’s Electronic Submissions Gateway.
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- New HHS Policy on Buprenorphine for the Treatment of Opioid Use Disorder – Finally, Treatment is More Accessible than Opioids…. UPDATE January 26, 2021
- HP&M’s Frank Sasinowski to Present at Kinexum’s “Wow or Yeow?! FDA Outlook for 2021 and Beyond” January 25, 2021
- Most Favored Nation Drug Pricing Rule on Hold Awaiting Changes January 22, 2021
- FDA Continues Discussion of AI/ML Software Medical Devices January 21, 2021
- Proposed Changes to Short-Form Version of Safe Harbor Proposition 65 Warning January 20, 2021
- 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