section opinion letters 
FDA Law Blog
JUNE 13, 2023
Wasserstein & Dara Katcher Levy — After about a year without any untitled letters from OPDP, Xeris Pharmaceuticals received an untitled letter for their promotion for Recorlev (levoketoconazole) for misleading safety and efficacy claims. By Jeffrey N.
FDA Law Blog
SEPTEMBER 29, 2021
The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.
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The Pharma Data
NOVEMBER 22, 2020
Cytokinetics has received positive feedback from key heart failure opinion leaders on the primary results, with particular interest in the potential role of omecamtiv mecarbil in the treatment of advanced heart failure patients who remain at risk for hospitalization despite being treated with standard of care regimens.
The Pharma Data
MAY 15, 2021
Description: If YOU don’t have time to read the entire letter… Then you can opt to claim your free PentagonFit Tracker right now. Or click “Continue Reading” to return to the letter. be used for these purposes, you must send a letter to the Online Privacy Coordinator whose. Claim your free PentagonFit Fitness Tracker now!
The Pharma Data
MARCH 5, 2021
Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. The CHMP scientific opinion under Article 5.3
The Pharma Data
MAY 15, 2021
After all… As Adam mentioned in the 5th section of this letter, humans evolved to eat according to these natural cycles. For more information you can check out the chapters in ‘The Health Benefits of Fasting’ section of Eat Stop Eat. You can check out the chapter ‘Fasting and your muscle mass’ for more information.
The Pharma Data
MAY 13, 2021
ClickBank’s role as retailer does not constitute an endorsement, approval or review of these products or any claim, statement or opinion used in promotion of these products. The Relationship of Sugar to Population-Level Diabetes Prevalence: An Econometric Analysis of Repeated Cross-Sectional Data. Neuroscience Letters.
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