March 13th 2020
The Center for Biosimilars® recaps the top stories for the week of March 9, 2020.
By Tony Hagen
In light of the COVID-19 outbreak, the FDA has suspended foreign inspections of FDA-regulated manufacturing plants and products. Meanwhile, escalating foreign travel restrictions put a damper on growth of the biosimilars industry.
March 6th 2020
The Center for Biosimilars® recaps the top stories for the week of March 2, 2020.
March 5th 2020
By Allison Inserro
Looking to March 23, the FDA released a question-and-answer guidance document for industry about the upcoming transition for how certain products will now be approved under a biological pathway, including exceptions to the transition and how companies will receive notifications about their applications.
March 1st 2020
By Skylar Jeremias
The FDA announced changes or updates to several policies. Chief among them: final guidance on a regulatory shift for insulin and certain other products.
February 29th 2020
The Center for Biosimilars® recaps the top stories for the week of February 24, 2020.
February 24th 2020
By The Center for Biosimilars Staff
Ultimately, the Purple Book is supposed to include all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products.
February 21st 2020
The FDA said it was no longer necessary to include the interpretation of the term “chemically synthesized polypeptide” as first proposed in December 2018.
February 18th 2020
The Office of Pharmaceutical Quality, charged with strengthening and building public trust in the US supply of medicine, notes that March 23, 2020, will mark a key turning point in the way that many biologics are licensed.
February 7th 2020
By Gianna Melillo
The agency will now review and act on original 351(k) biologics license application (BLA) supplements with clinical data within a 6-month time frame. Originally, such supplements had a 10-month goal date for review. In addition, applicants can now request the FDA refrain from taking action on supplements of 351(k) BLAs before a certain date.
