confused-drug-names Blog Related Topics 
The FDA Law Blog
AUGUST 17, 2023
Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling.
The FDA Law Blog
MARCH 12, 2024
Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. Rather, the FTC questioned whether these patents meet the statutory and regulatory criteria for listing in the Orange Book.
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The FDA Law Blog
JUNE 16, 2023
Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below.
The FDA Law Blog
JULY 10, 2023
In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. Federal Food, Drug, and Cosmetic Act, Section 513(i)(1)(D)(i).
The Social Pharmacist
JULY 28, 2022
This blog introduces you to various options below to make an informed decision in choosing the best email marketing software for your pharmacy business. Healthcare professionals are constantly on the lookout for the best drugs to prescribe. Hence, earning credibility as a drug manufacturer remains super-critical.
The deprescribing.org Blog
FEBRUARY 17, 2021
If a drug is started, documenting the reason for use is a must. Based on best practices, our electronic discharge prescriptions have evolved to include space for the doctor and pharmacist to document the rationale for drug changes plus any follow-up suggested. All of these pieces help continuity.
The Thyroid Pharmacist
JUNE 16, 2023
Black seed oil is derived from a plant that goes by many different names. Aside from its botanical name, Nigella sativa , it is also known as black cumin or black cumin seed. However, be careful not to confuse this plant with true culinary cumin ( Cuminum cyminum ), black pepper, black sesame, or black cohosh.
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