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Dec. 31, 2012 -- The U.S. Food and Drug Administration today approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Fulyzaq is the second botanical drug approved by the agency. Just as for other types of drugs, the safety and efficacy of a botanical drug product.....
On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law by U.S. President Obama. GDUFA requires pharmaceutical industry to pay user fees to supplement the costs of ANDA review and GMP inspection.....
FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) Requirements Relating to Human Drugs
- Country Taking Steps to Improve its Production and Regulatory Standards
Chinese Biogenerics and Protection of IP - Large Market Potential and Solid Foundation Set the Stage
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