- 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
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- Proposed Changes to Short-Form Version of Safe Harbor Proposition 65 Warning January 20, 2021
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In 1997, Congress directed FDA to use the “least burdensome” approach in reviewing device applications. This legislation resulted in little change in behavior. In 2012, Congress enacted new legislation with the same outcome.
In 21st Century Cures, Congress addressed the “least burdensome” approach for the third time. On December 15, 2017, FDA issued a Draft Guidance Document (see our previous post here).
The draft guidance contains some potentially positive implements, provided that they are actually implemented. Yet, based on FDA’s past conduct, doubts are inevitable. Hyman, Phelps & McNamara, P.C. has submitted comments to FDA regarding the draft guidance document.
Whether the “least burdensome” approach will truly be incorporated into practice or remain a largely meaningless phrase will not be known for some time. If truly embraced by FDA, the “least burdensome” approach could have a significant, positive impact on device regulation. The content of the final guidance, though, will provide important clues.
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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