Browsing Category

FDA

New Drugs Approvals by FDA and EMA: 2020 Recap

The year 2020 was an eventful year for the pharmaceutical industry, with several companies across the world working at a feverish pace to find a treatment or a vaccine for the raging Covid-19, which has so far taken over 1.79 million lives worldwide. With countries imposing lockdowns and…
Read More...

World Diabetes Day 2020

On the 14th of November is the annual World Diabetes Day. This year's theme is "The Nurse and Diabetes". Nurses currently account for over half of the global health workforce. They do outstanding work to support people living with a wide range of health concerns. People who either live with…
Read More...

USFDA’s list of drugs that need generic alternatives

In its continuous endeavor to bolster the competitiveness of the generics market, the US Food and Drug Administration (FDA) updated its list of ‘off-patent, off-exclusivity drugs without an approved generic’. The agency updates this list every six months to improve transparency and to encourage…
Read More...

FDA DMF filings 2020

In case you thought Covid-19 had slowed down the speed at which generic active pharmaceutical ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug Administration (FDA), you are in for a pleasant surprise. During the first half of this year, the industry…
Read More...

Pending Monographs for Excipients – Background & Guide

Do you want to use the USP Pending Monograph process? Or have you ever wondered what the USP Pending Monograph process is and how it works in detail? See our article explaining the PMP with a full overview or have a look at our summarizing video. Both are based on USP information. Moreover, you can…
Read More...

USP Comment to FDA Proposed Novel Excipient Review Program

The United States Pharmacopeia (USP) appreciates the opportunity to provide comments on a potential FDA novel excipient review program. USP is supportive of a novel excipient review program. Establishing new pathways for the development and regulatory review of novel excipients is critical in…
Read More...

The Comeback of Small Molecules?

Innovation drives progress in the development of new drugs and therapeutic biological products. 48 new drugs and biological products were approved by the FDA last year, which means new treatment options for patients and considerable advances in health. The majority of these new drugs…
Read More...