Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. First approved in 2014 to treat one condition, melanoma, Merck now lists 19 separate conditions it can treat — a massive boon for desperate patients. However, S.6 ASBM surveys of U.S.

Biosimilars 130

Biosimilars Drug Pricing Packaging Labelling 130

RX Note

JUNE 8, 2023

In the past, package inserts were not always reliable sources of information regarding medication safety during lactation. As a general rule, breastfeeding is considered acceptable when the relative infant dose is <10%.

Labelling 52

Labelling Packaging 52

RX Note

MARCH 23, 2023

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

Compounding 52

Compounding Sterile Compounds Packaging Labelling 52

Syner-G

AUGUST 9, 2022

Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. 5 clinical study reports. All clinical components of the NDA, including the Integrated Summaries of Efficacy and Safety (ISE and ISS), the Summaries of Clinical Efficacy and Safety (Modules 2.7.3

Documentation 40

Documentation Packaging Labelling 40

European Pharmaceutical Review

FEBRUARY 22, 2023

The payload is packaged inside a dissolvable needle, loaded within a microsyringe that is attached to a folded, self-inflating balloon. Results from the first open-label, single-centre study of RT-101,6 which was conducted in Australia, were reported at the start of 2020. the enteric coating and the capsule dissolve.

Biosimilars 105

Biosimilars Diabetes Immunity Immunization 105

Birth Control Pharmacist

SEPTEMBER 20, 2021

While not stated in the current package insert, data are emerging that support fewer breast tissue effects and breakthrough bleeding than older oral contraceptives. Nextstellis (Drospirenone and Estetrol) [package insert]. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf. Accessed June 25, 2021.

Adverse Reactions 52

Adverse Reactions Packaging Labelling Diabetes 52

The Thyroid Pharmacist

JULY 29, 2022

Back in 2014, I found that my Hashimoto’s flared up after using a particular lip gloss; once tested, it came back as containing arsenic! . Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, Wildfire Emissions and Particulate Matter.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52