OR WAIT null SECS
December 17, 2014
The agency publishes two guidance documents on providing regulatory submissions in electronic format.
December 05, 2014
The guidance seeks to help generic and biosimilar drug sponsors gain access to reference products from brand-name manufacturers.
December 03, 2014
CytRx receives formal written communication from FDA on a prior decision for a partial clinical hold for CytRx's trials involving chemotherapeutic agent aldoxorubicin.
November 20, 2014
Revised EMA policy reflects more balanced approach and experts are to submit updated declarations of interests by end of January 2015.
November 12, 2014
The European Medicines Agency responds to the European Ombudsman?s letter regarding redacted documents.
October 20, 2014
The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.
October 10, 2014
The European Medicines Agency releases highlights from its Pharmacovigilance Risk Assessment Committee safety review meeting in October.
October 07, 2014
FDA outlines procedures for having a Critical Path Innovation Meeting with CDER.
FDA draft guidance outlines ways to minimize risk from acetaminophen-containing over-the-counter pediatric liquid drug products.
September 16, 2014
FDA releases guidance on ANDAs and PASs submissions to help applicants avoid deficiencies.