동향

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1367 Radioactive Drug, New Drug Application The Radioactive Drug Research Committee: Human Research Without An Investigational New Dryg Application FDA 2015-07-27 2685
1366 New Drug Application Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations FDA 2015-07-27 3065
1365 New Drug Application New Drug Application (NDA) FDA 2015-07-27 2667
1364 Investigational New drug application Small Business Assistance: Frequently Asked Questions on Drug Development and Investigational New Drug Applications FDA 2015-07-27 2433
1363 Investigational New drug application CDER Regulatory Applications - Investigational New Drug and New Drug Application FDA 2015-07-27 2427
1362 Investigational New drug application Guidance Investigational New Drug Application for Positron Emission Tomography (PET) Drugs FDA 2015-07-27 2360
1361 Investigational New drug application Emergency Investigational New Drug (EIND) Applications for Antiviral Products FDA 2015-07-27 2408
1360 New Drug, CDER CDER New Drug Review FDA 2015-07-27 2319
1359 New Drug, IND Number of biosimilar investigational new drug applications (INDs) received in the month FDA 2015-07-27 2388
1358 New Drug Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies FDA 2015-07-27 2260