article thumbnail

Securing every dose with an edible security technology for safe medicines

European Pharmaceutical Review

On- or in-dose authentication means that a security measure or anticounterfeit feature is integrated with the dosage form itself, offering product verification and traceability embedded into each medicine, rather than on the secondary package” WHO estimates that >50 percent of the drugs for sale on the internet are fake.

Dosage 92
article thumbnail

eMDR System Enhancements

The FDA Law Blog

Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. For any major changes, additional time will be granted between the release of the implementation package and production deployment.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Norepinephrine vs Epinephrine Post Cardiac Arrest

Pharmacy Friday Pearls

Mion, 2014 Case report N=1 • Epinephrine then transition to norepinephrine • 58 year male, The cardiac rhythm turned into a ventricular fibrillation (VF). Epinephrine [package insert] Lake Forest, IL: Hospira, Inc.; 2014 Dec;32(12):1560.e1-2. 12.2] (P = 0.013) times higher in the EPI group compared to NE treated patients.

Dosage 40
article thumbnail

What is a dangerous A1C level?

The Checkup by Singlecare

That can mean opting for more whole foods such as vegetables, fruits, complex carbs, and lean protein while decreasing your intake of processed foods with lots of added sugar and simple carbohydrates, such as packaged baked goods, soda, or juice. Regularly exercise.

Packaging 105
article thumbnail

Guido Rasi steps down, handing the running of EMA to Emer Cooke

pharmaphorum

In his final message as head of the EMA, Rasi said the number of COVID-19 drugs and vaccines being developed by pharma companies is “encouraging,” and pointing to the agency’s pivotal role “in reviewing the available data packages to ensure that our usual high standards of safety, efficacy and quality are achieved and upheld.”.

article thumbnail

Case Study 2 – The Journey Leading to an Approved NDA

Impact Pharmaceutical Services

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

article thumbnail

Case Study 6 – Regulatory Operations Department Developed and Flourishing

Impact Pharmaceutical Services

By early 2014, the Regulatory Operations group was fully operational and ready to offer electronic publishing services to IMPACT’s clients. During the last year, IMPACT has submitted several FDA meeting packages for this consultant as well.

FDA 40