2016 Communication Labelling 
RX Note
DECEMBER 25, 2024
Introduction Guide to Good Dispensing Practice, 2016 is developed to ensure that medicines are dispensed in accordance with the laws and guidelines in both government and private health care facilities in Malaysia. Labelling Requirements A ll dispensed medicine should be labelled according to the requirement stated by the law.
Eye on FDA
AUGUST 22, 2023
The Untitled Letter posted this week involved an oral birth control pill which has a specific of contraindications contained in the label as well as a list of warnings and precautions and of the most common adverse events. The communications vehicle in question was a social media sponsored posting. Pharma communicators take note.
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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.
FDA Law Blog: Biosimilars
APRIL 25, 2023
The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers. It applies whether the software is the entire device (i.e., Software in a Medical Device, or SiMD). Loose Ends IDEs.
pharmaphorum
JULY 11, 2021
The acting FDA commissioner has sent a letter to the Department of Health and Human Services (HHS) inspector general Christi Grimm on Friday, asking for a review of the communications between the FDA and the company and the process that led to the approval of Aduhelm (aducanumab). pic.twitter.com/iWJNxdZ5Cs.
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]. Identify the medullary pyramids, calyces, renal cortex, and renal pelvis (Figure 4).
European Pharmaceutical Review
SEPTEMBER 22, 2023
Yves joined AC Immune in 2020 and is now Manager, Investor Relations and Communications. She is currently CEO and successfully led the IPO on Nasdaq in 2016. Lecanemab (BAN2401) infusion reactions and immunogenicity: results from randomized phase 2 study and an open-label extension. Brain Communications.2022;4(1).
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