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FDA changes Hepatitis C Devices Categorization SHEM OIRERE
December 17, 2021
To Support Global efforts to test and treat chronic hepatitis C has received a major boost from the Food and Drug Administration (FDA) after the US-based regulator issued a final order for the reclassification...
Electronic Drug Registration and Listing (eDRLS) Lin Zhang
December 02, 2021
Last month (October 13, 2021), the Food and Drug Administration (FDA) held a conference that is part of the CDER Small Business & Industry Assistance (SBIA) Regulatory Education for Industry (REdI) series.
Analysis on the Layout of Innovative Drugs in China and Globally PharmaSources/Zhulikou431
October 27, 2021
Recently, there is a saying in the pharmaceutical industry: not all innovative drugs have a future. This saying reminds me of the lyrics - wild lilies also have spring.
Advancing Generic Drug Development to Approval Lin Zhang
October 22, 2021
The FDA continuously works to change and improve their work, including the work done with generic drugs. Last month, September 21-22, 2021, the Food and Drug Administration (FDA) hosted a workshop...
ADUHELM: The First FDA Approved Therapy for Alzheimer’s Disease Since 2003 Lin Zhang
July 20, 2021
Aducanumab, known as ADUHELM, was co-developed by Biogen and Eisai and newly approved by the United States Food and Drug Administration (FDA) on June 7, 2021 (BLA 761178) under the provisions of accelerated approval regulations (21 CFR 601.41).
Pharmaceutical Companies Back to the Blue Ocean of AD in the Wake of Aduhelm's Approval PharmaSources/Yefenghong
July 20, 2021
On June 8, the FDA issued an accelerated approval to Biogen/Eisai's powdered protein antibody Aduhelm (generic name aducanumab) for the treatment of Alzheimer's disease (AD).
Good News in the Anti-AβAntibodies Field, Two Drugs were Successively Granted Breakthrough Drug Qualification by the FDA PharmaSources/Dopine
July 13, 2021
Two AD drugs have been granted BTD by the FDA recently, namely Eisai/Biogen's Lecanemab (BAN2401) and Eli Lilly's Donanemab.
Rare Disease Drug 101 - What are the Benefits to Apply for and Receive Orphan Drug Designation? Lin Zhang
June 29, 2021
There are many common diseases that affect millions of people across the world. On the other hand, there are so-called rare conditions that affect a small number of people.
New Development of FDA Regulations on Complex Generic Drugs PharmaSources/Zhulikou431
June 03, 2021
Since the promulgation of the Hatch-Waxman Act in 1984, in order to promote drug competition and improve public drug availability, FDA has formulated a number of policies aimed at accelerating the marketing of generic drugs.
What’s New on FDA Generic Drugs Forum 2021? LIN ZHANG
May 08, 2021
Once a year, the Generic Drugs Forum was held on April 28 - 29, 2021 by the FDA Office of Generic Drugs (OGD).

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