Related by context. Frequent words. (Click for all words.) 58 Complete Response 57 License Application 54 Citizen Petition 52 FDA Accepts 52 Warning Letter 51 Position Statement 50 END FOOTNOTE 50 Hr'g Tr 50 Jack Boland QMI 49 Resp 49 First Amended Complaint 48 Adverse Event Reporting 48 Dkt 48 Approval Process 48 Complete Response letter 48 Complete Response Letter 47 Approvable Letter 47 Issues Guidance 47 Comment Period 47 Permit Application 47 Doc. No. 47 NOPR 47 Ethics Complaint 46 Anthrax Vaccine 46 Mitigation Strategy 46 Rehearing 46 Panel Rejects 46 Priority Review 46 FDA approvable letter 46 Declaratory Judgment 46 Senate Panel Approves 46 Compl 46 Panel Votes 45 Single Dose 45 Certiorari 45 Act PDUFA date 45 Medication Errors 45 Reporting Requirements 45 Filing Deadline 45 Reexamination 45 Reorganization Plan 45 Deadline Approaching 45 Marketing Authorization Application 45 Generic Version 45 Sole Source 45 Smallpox Vaccine 44 Rulemaking 44 SUPPLEMENTARY INFORMATION 44 European Medicines Evaluation 44 Slip op 44 FDA Orphan Drug 44 FDA Advisory Panel 44 sNDA 44 Settlement Agreements 44 Preliminary Injunction 43 Provides Guidance 43 Patent Infringement Lawsuit 43 Boxed Warning 43 Shelf Registration Statement 43 Fee Schedule 43 Paragraph IV Certification 43 Prescription Drug User Fee 43 Permanent Injunction 43 By gna Ghana 43 User Fees 43 sBLA 43 Egg Recall 43 Doc. 43 punctuation omitted 43 Reconsideration 43 Clinical Trials Update 43 FAR #.#-# [003] 43 FONSI 43 NASDAQ Listing 43 FY# Guidance 42 Jobless Benefits 42 customer service@ambest.com 42 Panel Urges 42 DDMAC 42 Panel Backs 42 Proposed Changes 42 Final EIS 42 Litigation Settlement 42 Staff Determination Letter 42 Congressional Oversight 42 Plaintiff Motion 42 FDA 42 Paragraph IV 42 Defendants Motion 42 Drug Application 42 Panel Approves 42 Authorization 42 Drug Makers 42 Fast Track Designation 42 Regulatory Requirements 42 Preliminary Approval 42 Recusal 42 Corrective Action 42 Electronic Prescribing 42 Marketing Authorisation 41 Delays Filing