Government Manufacturing Patients Specialization 
FDA Law Blog
MARCH 6, 2024
His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceutical companies to CROs and academic researchers to patient advocacy organizations. We can offer our readers a special discount for the event. The discount code is S10-896-896L24.S. Details on the conference can be found here.
FDA Law Blog
MAY 7, 2025
Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Physicians had ultimate control and exercised independent judgment over their patients healthcare decisions. Mallory , 988 F.3d 3d 730 (4th Cir. Medicare or Medicaid).
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FDA Law Blog
MAY 3, 2021
Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation.
FDA Law Blog
JUNE 7, 2023
The cases were both brought under the False Claims Act (FCA), the Civil War-era law that the government uses to claw back funds it pays out to parties that overbill federal programs. The FCA incentivizes whistleblowers to come forward by awarding them a cut of any recovery. What was SuperValu all about?
FDA Law Blog
MAY 3, 2021
Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation.
FDA Law Blog
APRIL 8, 2024
For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”
GeriPal
DECEMBER 7, 2023
I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. And that’s a good thing to share with an older patient or client that making decisions about your activity. So how are your patients going to deal with extreme heat and cold?
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