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Update on FDA’s Comprehensive Regenerative Medicine Policies and Enforcement Activities
… (RMAT) designation program created with passage of the 21st Century Cures Act. The first final guidance, Expedited Programs for …
The AI Search Engine Doctor Is Always In: What Are the Regulatory and Legal Implications?
… device based on the specific exemptions created by the 21st Century Cures Act (see our previous posts on the Cures Act and CDS …
FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership
… FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership December 18, 2017 | Blog | …
HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part V: Cybersecurity Technology and Electronic Health Records
… few legal avenues to prevent information blocking, but the 21st Century Cures Act has now given ONC and OIG more direct authority to …
Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started
… changing ways that people purchase and consume food in the 21st century. On the enforcement side of the FDA’s diverse and … mandated by Congress in the now-five-year-old 21st Century Cures Act , releasing four draft guidances (see here , here …
FDA’s Holiday Present from Congress: Bipartisan Reforms to the Accelerated Approval Framework, Long-Awaited Cosmetic Modernization, and Expansion of Certain Existing Programs
… information safe harbor in December 2016 as part of the 21st Century Cures Act (which we blogged about at the time here ); and …
FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round
… a similar program into law for medical devices in the 2016 21st Century Cures Act.) At the same time, however, PDUFA VI has some …
ML Strategies COVID-19 Insights Week In Review — May 1, 2020
… Chain Negotiations Underway on Additional Stimulus Measures 21st Century Cures 2.0 Senators Seek Phase 4 Stimulus Provisions for …
The Future of the Affordable Care Act Week 7: The American Health Care Act
… small employer health reimbursement arrangement” under the 21st Century Cures Act. Employer Reporting The bill also makes …
Washington Outlook for 2016
… plate this year include a response to the outcome of the 21st Conference of Parties to the United Nations Framework … achieving carbon neutrality by the second half of the century; adapting to adverse climate impacts and fostering … passage of its version of the House-passed 21st Century Cures Act, enacting legislation around the Senate chronic …