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User fee increase coming?

Executive Summary

Jerome Stevens Pharmaceuticals is seeking $1.3 bil. from FDA for the agency's "unlawful publication of trade secrets and confidences" for Unithroid on its web site, the company announces March 26. The claim approaches the agency's $1.7 bil. annual operating budget. FDA posted trade secrets from its October 1999 levothyroxine NDA from Aug. 22, 2000 to Jan. 23, 2001, the company said. JSP will sue the agency in D.C. federal court if FDA fails to act on the tort claim within six months...

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Generic Unithroid approval

FDA approves Mylan ANDA for Jerome Stevens' Unithroid (levothyroxine) on June 5. Jerome Stevens is seeking $1.3 bil. from FDA for allegedly posting trade secrets from its NDA, approved in August 2000, on the agency website (1"The Pink Sheet" April 1, In Brief)...

ImClone Erbitux Hearing Will Include Five FDAers Under Subpoena

The House Energy & Commerce/Oversight Subcommittee has subpoenaed five FDA witnesses to appear at a June 13 hearing on issues surrounding the refuse-to-file letter for ImClone's Erbitux

Big Data Offers International Benefits

The HMA-EMA Big Data Task Force has offered recommendations to use data for the benefit of public health.




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