FDA Issues New Guidance: Why Your ANDA Was Refused
On Wednesday, the FDA announced two guidance documents intended to assist applicants preparing to submit ANDAs, clarifying the deficiences that may cause the FDA to refuse-to-receive the submissions.
FDA Warns Ebola Treatments for Sale are Fake
The U.S. FDA is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus -- a scam that has gained momentum since the outbreak of the Ebola virus in West Africa.
Apotex Loses NAFTA Dispute with FDA
Apotex Inc. announced that a arbitration tribunal constituted under Chapter Eleven of the North American Free Trade Agreement has rejected the company's claims that the FDA violated NAFTA by prohibiting imports of Apotex products from two plants in Ontario, Canada.
India Issues New GMP-Inspection Rules
India’s Central Drugs Standard Control Organization (CDSCO) has issued new guidelines for state inspectors on how to prepare for and conduct GMP inspections of drug manufacturing facilities.