FDA Law Blog
JANUARY 15, 2024
Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. FDA extended PMTA compliance deadlines for years so it could figure out appropriate application instructions and so that manufacturers could figure out how to comply.
My Green Doctor
MAY 3, 2025
For instance, the UK government’s initiative to install solar panels on National Health Service sites is projected to save each site up to £45,000 annually, amounting to approximately £13 million in total savings per year. The product manufacturers and vendors will need to be active partners as well.
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Georgetown Pediatrics & Family Medicine
MAY 11, 2022
If not, your pediatrician’s office can work with you to access all community resources. Always mix formula as directed by the manufacturer. I heard the government will be importing baby formula from other countries. This is a very difficult problem. This should never be done. Can I make my own baby formula? Is that safe?
FDA Law Blog
MARCH 6, 2024
Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. As the co-founder of HP&M’s FDA Law Blog , Kurt often leads the response to new rules and regulations, sharing his interpretation with the broader legal community.
FDA Law Blog
JUNE 15, 2022
Kirschenbaum — In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. By Faraz Siddiqui & Alan M. 52494 (Nov.
FDA Law Blog
OCTOBER 17, 2023
This 2022 draft guidance proposed that certain non-addictive medical products for pain or addiction treatment could be eligible for breakthrough designation, aligning with the Agency’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.
GeriPal
MARCH 2, 2023
And for that reason, there was actually an enormous lawsuit, and the manufacturer was fined, now I think 20 years ago, in the millions and millions of dollars for off-label prescribing. Eric: Although pregabalin, right, more misuse of pregabalin out in the community. So that’s kind of how it first came on my radar. Is that right?
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