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The FDA has withdrawn at least 10 draft guidances for drugmakers published before the end of 2013 because they had become outdated or were superseded by higher agency priorities.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
Between 2013 and 2014, the European Medicines Agency nearly doubled, to 40 percent, the percentage of drug adverse event assessments that led to a recommendation for updated patient information on labeling, a new report says. Read More
Sponsors seeking Canadian approval of new drugs or indications based on published literature or postmarketing data need to be able to prove that their drug is comparable to its reference product, Health Canada says. Read More
Drugmakers should summarize medication errors that don’t result in adverse reactions in periodic safety update reports and in their risk-management plans, the European Medicines Agency says. Read More