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The European Medicines Agency is tightening its rules around conflicts of interest, barring individuals who take jobs in industry from serving on any of its advisory committees. Read More
The FDA has withdrawn at least 10 draft guidances for drugmakers published before the end of 2013 because they had become outdated or were superseded by higher agency priorities. Read More
Manufacturers must submit all NDA, ANDAs, BLAs and drug master files electronically by May 15, 2017, and all commercial INDs one year later, under an FDA final guidance. Read More
Sponsors of INDs, NDAs, ANDAs and supplemental applications for drugs that are highly soluble in water but not easily absorbed through the intestines can now request waivers of studies proving the drug has a systemic effect or is equivalent to a reference product. Read More
The FDA is not requiring ordinary proof of effectiveness as it strives to approve orphan drugs for some 7,000 diseases, only 300 of which currently have treatment options, a new study concludes. Read More