357 results on '"United States. Center for Drug Evaluation and Research"'
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2. FDA approves Neffy, a nasal spray alternative to an EpiPen that does not need a needle to stop an allergic reaction
3. Zuranolone Approved as First, Only Oral Medication to Treat Postpartum Depression
4. Delta-9-Tetrahydrocannabinol and Cannabidiol Drug-Drug Interactions
5. CDISC is Proud to Announce a Research Collaboration to Incorporate FDA Business Rules into CDISC's Open Rules Engine (CORE)
6. Prothena Announces Appointment of Billy Dunn, M.D., to its Board of Directors
7. Prothena Announces Appointment of Billy Dunn, M.D., to its Board of Directors
8. CLINICAL ANALYST CAREERS AT CDER
9. Kerala DC calls on IPEC to adopt US FDA guidance to ensure quality of excipients used in drug formulations
10. MindMed adds Robert Dworkin to its Scientific Advisory Board
11. FDA DRAFT GUIDANCE ADDRESSES USE OF EXTERNAL CONTROLS TO ASSESS EFFECTIVENESS OF NEW DRUGS AND BIOLOGICS
12. STAT to hold The ASCO Recap webinar
13. CN Bio expands partnership with FDA to investigate lung-on-a-chip model for inhaled drug evaluation applications
14. FDA, CDC EXPERTS: WHAT PHYSICIANS NEED TO KNOW ABOUT TPOXX FOR TREATMENT OF MONKEYPOX, PART 1
15. FDA Ramped up Approval Rate in 2017: FDA looks to achieve near-record level of new drug approvals following slowdown in 2016
16. Amag drops 3% after FDA proposes withdrawal of Makena from market
17. Studies in the Area of Potassium Ion Binding Activity Reported from Center for Drug Evaluation and Research (Quantification of Monomer Units in Insoluble Polymeric Active Pharmaceutical Ingredients Using Solid-State NMR Spectroscopy I: Patiromer)
18. Q2 2021 Alexandria Real Estate Equities Inc Earnings Call - Final
19. Biologic NMEs Maintain Strong Presence in 2017 Drug Approvals: Biologic new molecular entities (NMEs) accounted for 26% of total NME approvals in 2017
20. Horizon Therapeutics PLC To Discuss TEPEZZA Supply Disruption Call - Final
21. Q4 2019 Lexicon Pharmaceuticals Inc Earnings Call - Final
22. Tetra Bio Pharma announces FDA determination on evaluation of CAUMZ Kit
23. FDA Drug Approvals Hit Record Levels in 2017; Gene therapies highlight FDA new drug approvals in 2017
24. MindMed Engages in Productive Pre-Submission Meeting with FDA for Development of the MindMed Session Monitoring System
25. MindMed Engages in Productive Pre-Submission Meeting with FDA for Development of the MindMed Session Monitoring System
26. FDA SHARES RESEARCH TO IMPROVE DOSE SELECTION IN PEDIATRIC DRUG DEVELOPMENT
27. 10-Q: NAVIDEA BIOPHARMACEUTICALS, INC
28. FDA TOUTS SUCCESS AND CHALLENGES IN BIOSIMILAR DEVELOPMENT
29. The Impact of Patents and Exclusivities on FDA's Approval of Generic Drugs
30. FDA OFFICIALS TOUT PROGRESS AND ACHIEVEMENTS IN ADVANCED MANUFACTURING
31. CDER CONVERSATION: NOVEL EXCIPIENT REVIEW PILOT PROGRAM
32. CLINICAL TRIAL DESIGN FOR NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) - 11/18/2021 - 11/19/2021
33. FDA GUIDANCE COVERS FREQUENTLY ASKED CMC QUESTIONS FOR GENERIC DRUGS
34. Good ad or bad ad? FDA quiz reminds docs about its Bad Ad program to police problematic advertising
35. FDA DRUG INFO ROUNDS VIDEO
36. NOVEL EXCIPIENT REVIEW PILOT PROGRAM
37. CAUSING THE INTRODUCTION OF UNAPPROVED AND MISBRANDED DRUGS INTO INTERSTATE COMMERCE
38. BEST PRACTICES FOR DEVELOPMENT AND APPLICATION OF DISEASE PROGRESSION MODELS - 11/19/2021 - 11/19/2021
39. FDA PROPOSES TO REFUSE INTARCIA'S EXENATIDE COMBO PRODUCT NDA --AGAIN
40. BioCryst Appoints Dr. Steven Galson to Board of Directors
41. American College of Rheumatology Update on Tocilizumab Shortages
42. FDA veteran and outspoken expert Unger retires as the agency finds itself at a crossroads
43. FDA inks $49.9 million deal with SAS
44. Lexicon Pharmaceuticals Inc Receives Formal Dispute Resolution Request Decision From FDA's Office of New Drugs For Sotagliflozin In Type 1 Diabetes Call - Final
45. USFDA renews, expands use of Certara software to facilitate new drug & biologics regulatory review
46. Alnylam selloff yesterday on CDER document overblown, says Piper Jaffray
47. FDA TO AMAZON: STOP SHIPPING PRODUCTS THAT CONTAIN UNDISCLOSED DRUGS
48. FDA submits controversial Alzheimer's drug for HHS review
49. PROVIDING REGULATORY SUBMISSIONS IN ALTERNATE ELECTRONIC FORMAT GUIDANCE FOR INDUSTRY
50. ConcertAI and the FDA to Collaborate to Advance the Knowledge on the Potential uses of Real-World Evidence
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