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FDA Special Protocol Assessment
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1	Microsoft Word - Savient press release Puricase SPAdoc Add to Reading List Source URL: www.mvpharm.com Language: English - Date: 2016-07-11 17:00:21 Medical research Pharmacology Health Food and Drug Administration Pharmaceutical industry Clinical research Drug discovery PEGylation Pharmacokinetics Savient pharmaceuticals Pegloticase FDA Special Protocol Assessment
2	Microsoft Word - Savient Announces FDA Advisory Paneldoc Add to Reading List Source URL: www.mvpharm.com Language: English - Date: 2016-07-11 16:59:17 Savient pharmaceuticals Food and Drug Administration Pegloticase Health FDA Special Protocol Assessment Priority review Forward-looking statement Oxandrolone
3	Microsoft Word - 9124dft.doc Add to Reading List Source URL: www.fda.gov Language: English Design of experiments Clinical research Pharmaceutical industry Pharmacology Clinical trial Interim analysis Clinical study design Drug development FDA Special Protocol Assessment Medical statistics Science Research
4	ACUSPHERE INC. REACHES SPECIAL PROTOCOL ASSESSMENT AGREEMENT WITH FDA FOR IMAGIFY™ PHASE 3 PLACEBO-CONTROLLED TRIAL LEXINGTON, MASS., June 8, [removed]Acusphere, Inc. (ACUS.PK), a specialty pharmaceutical company, today Add to Reading List Source URL: www.acusphere.com Language: English - Date: 2011-10-26 19:37:10 Science Clinical research Design of experiments Evaluation methods Food and Drug Administration FDA Special Protocol Assessment Clinical trial Ultrasound Pharmacovigilance Medicine Pharmacology Pharmaceutical sciences
5	Microsoft Word - Starpharmadocx Add to Reading List Source URL: www.starpharma.com Language: English - Date: 2014-07-14 20:17:07 Food and Drug Administration Pharmacology Clinical research Pharmaceutical industry Microbicides for sexually transmitted diseases Docetaxel FDA Special Protocol Assessment New Drug Application Clinical trial Pharmaceutical sciences Medicine Health
6	Microsoft Word - 16618dft.doc Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act Center for Biologics Evaluation and Research Biosimilar FDA Special Protocol Assessment New Drug Application Generic drug Center for Drug Evaluation and Research Biologic Food and Drug Administration Pharmaceutical sciences Medicine
7	Electronic Submissions and Standards Presentation to CDER Global Forum June 23, 2014 Mary Ann Slack Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Clinical research Pharmaceuticals policy Therapeutics FDA Special Protocol Assessment Abbreviated New Drug Application Center for Drug Evaluation and Research Drug development Generic drug Pharmaceutical sciences Food and Drug Administration Pharmacology
8	[removed]Gadoterate Statistical PREA Add to Reading List Source URL: www.fda.gov Language: English Clinical research Brain tumor Gadopentetic acid Guerbet FDA Special Protocol Assessment Gadoteric acid Clinical trial Magnetic resonance imaging Food and Drug Administration Medicine Pharmaceutical sciences Pharmacology
9	Summary Basis for Regulatory Action Template v 2 Add to Reading List Source URL: www.fda.gov Language: English Clinical research Health Pharmaceutical industry Drug safety Pharmacology FDA Special Protocol Assessment New Drug Application Clinical trial Validation Food and Drug Administration Medicine Research
10	FDA-Industry PDUFA V Reauthorization Meeting Add to Reading List Source URL: www.fda.gov Language: English Pharmaceuticals policy Pharmaceutical sciences Prescription Drug User Fee Act Center for Biologics Evaluation and Research Criticism of the Food and Drug Administration FDA Special Protocol Assessment Food and Drug Administration Medicine Health