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Drug user
Results: 1369

#	Item
401	FY 2013 GDUFA USER FEE PERFORMANCE REPORT Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Health Food and Drug Administration Clinical research Abbreviated New Drug Application Generic drug Drug Price Competition and Patent Term Restoration Act Prescription Drug User Fee Act New Drug Application Pharmaceutical sciences Pharmaceuticals policy Pharmaceutical industry
402	NDAs and BLAs: Communication to Applicants of Planned Review Timelines Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Prescription Drug User Fee Act Federal Food Drug and Cosmetic Act New Drug Application Center for Drug Evaluation and Research FDA Fast Track Development Program Food and Drug Administration Medicine Health
403	Microsoft PowerPoint[removed]18GJB_GPhA.ppt Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Clinical research Pharmaceutical industry Abbreviated New Drug Application Generic drug Bioequivalence Center for Drug Evaluation and Research Prescription Drug User Fee Act Pharmaceutical sciences Pharmacology Pharmaceuticals policy
404	BUDGET EXHIBITS SUMMARY OF CHANGES (dol l ars i n thousands) Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Food and Drug Administration Drugs Prescription Drug User Fee Act Mammography Quality Standards Act Pharmaceutical industry Biosimilar Generic drug Pharmaceuticals policy Health Medicine
405	FDA Safety and Innovation Act Add to Reading List Source URL: www.fda.gov Language: English Medicine Food and Drug Administration Pharmaceuticals policy Prescription Drug User Fee Act Biosimilar Biologic Drug resistance Pharmacology Pharmaceutical sciences Clinical research
406	United States Government Accountability Office GAO Report to Congressional Requesters Add to Reading List Source URL: maloney.house.gov Language: English - Date: 2009-01-13 15:51:32 Medicine Pharmaceutical sciences Drug safety Drugs Emergency contraception Prescription Drug User Fee Act Center for Drug Evaluation and Research Over-the-counter drug New Drug Application Food and Drug Administration Pharmaceuticals policy Pharmacology
407	SOPP[removed]: Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants Version #5 Effective Date: October 15, 2012 I. Purpose Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences FDA Special Protocol Assessment Prescription Drug User Fee Act New Drug Application FDA Fast Track Development Program Center for Biologics Evaluation and Research Meeting Investigational New Drug Validation Food and Drug Administration Medicine Health
408	st 21 Century Review Judit Milstein Add to Reading List Source URL: www.fda.gov Language: English Prescription Drug User Fee Act Pharmacology Health Drug safety Patent law New Drug Application Priority right Food and Drug Administration Pharmaceutical sciences Pharmaceuticals policy
409	FDAAA Accomplishments – One Year After Enactment Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Prescription Drug User Fee Act Adverse Event Reporting System ClinicalTrials.gov Center for Biologics Evaluation and Research Federal Food Drug and Cosmetic Act Unique Device Identification Validation Direct-to-consumer advertising Food and Drug Administration Medicine Health
410	Guidance for Industry Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees Add to Reading List Source URL: www.fda.gov Language: English Pharmaceuticals policy Pharmaceutical sciences Pharmacology Clinical research Food law Prescription Drug User Fee Act Bioequivalence Center for Biologics Evaluation and Research Clinical trial Food and Drug Administration Health Medicine

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