Biocompatibility is one of the most critical performance studies that manufacturers need to perform as part of their...
Nikita Angane
Electronic Signatures Under 21CFR§11
In the work from home era, we all realized how important it is to digitize our important documents and what a...
FDA’s Initiative for Protecting Women’s Health
National Women’s health week is a week-long observance by the US Department of Health and Human Services’ Office on...
EU’s New Guidance on Harmonized Standards
The EU Commission released a new guidance document clarifying the purpose of harmonized standards under the EU Medical...
Stability Testing Requirements for Pharmaceuticals
Deciding how and when to conduct stability tests on your new drug can be challenging. Stability tests provide evidence...
The SWIXIT Dilemma for Medtech- Part II
The new EU Medical Device Regulation is set to enter into force on May 26, 2021, which is less than a month away now....
The USMCA Agreement
FDA played a key role in the negotiations of the United States-Mexico-Canada Agreement. The agreement entered into...
The SWIXIT Dilemma for Medtech – Part I
Now that the world is done dealing with the Brexit drama, there is more on the plate for the EU Commission. The EU...
Software Systems: Medical Device or Not?
The 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)...
Accreditation Scheme for Conformity Assessment (ASCA)
FDA launched the ASCA Pilot on September 25, 2020. This pilot would grant ASCA recognition to qualified accreditation...
Enforcement Mechanisms Available to the FDA
The mission of the Food and Drug Administration is to protect public health by ensuring compliance of products and...
FDA’s Pandemic Recovery and Preparedness Plan
On April 2nd, 2021, the FDA provided an update on its Pandemic Preparedness and Recovery Plan (PREPP) Initiative. The...
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