2014 Communication Labelling 
RX Note
DECEMBER 25, 2024
Labelling Requirements A ll dispensed medicine should be labelled according to the requirement stated by the law. NOTE: It is advisable for labels to be printed. Consequently, a patient-centred label strategy is introduced to promote appropriate medication use and adherence. Suggestions include Use larger font sizes (e.g.
FDA Law Blog: Biosimilars
JANUARY 12, 2025
Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).
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Pharmaceutical Technology
JUNE 16, 2025
At the 2025 Congress of the European Hematology Association (EHA 2025), held from 12 June 12 to 15 June in Milan, Italy, preliminary dose-escalation and optimisation results from the global, multicentre, open-label, single-arm Phase I/II SYRUS clinical trial (NCT06137118) were presented on the second day.
FDA Law Blog: Biosimilars
OCTOBER 24, 2023
By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).
Eye on FDA
AUGUST 2, 2022
There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.
Eye on FDA
JUNE 14, 2023
The numbers plummet in 2014 until the record low last year of only 4 letters. The label for the medicine includes a boxed warning regarding potential issues related to complications for the liver (toxicity) and heart (QT prolongation). The last letter issued came just over a year ago in June, 2022.
ALiEM - Pharm Pearls
MARCH 7, 2024
Longitudinal view of the right kidney: Left – Probe placement in right mid-axillary line; Right – Unlabeled and labeled ultrasound view Video 1. Cysts will have a more spherical shape and will not “communicate” with one another [5]. 2014 Nov;22(4):213-22. Epub 2014 Nov 10. Ultrasound. cited 2023 July 4].
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