RX Note
DECEMBER 25, 2024
However, with the proliferation of biosimilars and liposomal or pegylated forms, health care professionals are now encouraged to communicate using product name for certain circumstances (e.g. bioavailability differences, release profile variations, biologics and biosimilars , licence variations and patient factors) to avoid confusion.
FDA Law Blog: Biosimilars
SEPTEMBER 26, 2023
Since I entered the life sciences industry in 2005, I’ve respected HP&M and admired their expertise and elite standing,” said Grizzel. “I Ellison, HP&M’s Managing Director. I’m incredibly excited by the opportunity to work for HP&M and its amazing group of professionals.
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FDA Law Blog: Biosimilars
AUGUST 21, 2023
Investigators also found that the pharmacy sold pseudoephedrine (“PSE”) products but failed to self-certify in violation of the Combat Methamphetamine Act of 2005 (“CMEA”). We note that in December 2020, the same U.S. 2, 2020 ( DOJ Press Release ). 21 U.S.C. § 830(e)(1)(B)(i).
European Pharmaceutical Review
JULY 4, 2024
4,6 Five patent issues that European biosimilar developers should consider before entering the US market Quality control of the botanical drug substances was one of the critical factors that led to barricades during the development of Veregen and Mytesi. 2005 [cited 2024May]. 2012/1916). Available from: [link] Barber S.
FDA Law Blog: Biosimilars
JUNE 11, 2023
This Draft Guidance, in part, replaces a 2005 guidance titled “How to Comply with the Pediatric Research Equity Act.”
FDA Law Blog: Biosimilars
MAY 23, 2023
Since then, the science and legal and regulatory framework for food allergens have evolved considerably: Congress enacted the Food Allergen Labeling and Consumer Protection Act (2004) and the Food Safety Modernization Act (2011), and FDA implemented the regulatory requirements set forth in 21 C.F.R.
European Pharmaceutical Review
OCTOBER 19, 2022
2 Recently, the US Patent and Trademark Office (US PTO) reiterated the concern that patents have been “misused to inhibit and delay – for years and even decades – competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” Patents are often described as the ‘lifeblood’ of pharmaceutical companies.
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