Search Results for complete response letter

Showing 1 – 3

Meeting With FDA After a CRL: Draft Guidance on What to Expect By Zachary Brennan - Published 13 October 2017

The US Food and Drug Administration (FDA) on Friday released new draft guidance for industry on the 30-minute post-complete response letter (CRL) meetings between FDA and abbreviated new drug application (ANDA) applicants to help clarify deficiencies.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: CRL, complete response letter, draft guidance

Federal Circuit Dismisses Amgen Appeal on Pfizer's Epogen Biosimilar By Zachary Brennan - Published 10 August 2017

The US Court of Appeals for the Federal Circuit on Thursday dismissed Amgen’s appeal related to a lawsuit over Pfizer’s Epogen (epoetin alfa) biosimilar.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Regulatory intelligence, Regulatory strategy

Tags: Epogen, epoetin alfa, complete response letter, Pfizer, Amgen

FDA Researchers Make Case for More Transparency When Drugs are Rejected By Alexander Gaffney, RAC - Published 12 June 2015

When the US Food and Drug Administration (FDA) finds reason not to approve a drug, it issues what is known as a Complete Response Letter (CRL) indicating its reasons for withholding approval and explaining which additional data might support an approval decision. Publicly-traded companies almost always communicate the issuance of these letters to the public, and generally summarize the points made by FDA in the letter. But how often do those companies tell the whole truth to their stockholders?

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration

Tags: CRL, Complete Response Letter