BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

519 related articles for article (PubMed ID: 20923624)

  • 1. What's next after 50 years of psychiatric drug development: an FDA perspective.
    Laughren TP
    J Clin Psychiatry; 2010 Sep; 71(9):1196-204. PubMed ID: 20923624
    [TBL] [Abstract][Full Text] [Related]  

  • 2. FDA's proposed regulations to expand access to investigational drugs for treatment use: the status quo in the guise of reform.
    Rossen BR
    Food Drug Law J; 2009; 64(1):183-223. PubMed ID: 19998746
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Regulatory watch: FDA guidance on co-developing investigational drugs.
    Nat Rev Drug Discov; 2011 Feb; 10(2):86. PubMed ID: 21283094
    [No Abstract]   [Full Text] [Related]  

  • 4. Regulatory issues in pediatric psychopharmacology.
    Laughren TP
    J Am Acad Child Adolesc Psychiatry; 1996 Oct; 35(10):1276-82. PubMed ID: 8885581
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Adverse effects in women: implications for drug development and regulatory policies.
    Parekh A; Fadiran EO; Uhl K; Throckmorton DC
    Expert Rev Clin Pharmacol; 2011 Jul; 4(4):453-66. PubMed ID: 22114855
    [TBL] [Abstract][Full Text] [Related]  

  • 6. FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment.
    Roller ST; Pippins RR; Ngai JW
    Food Drug Law J; 2009; 64(3):577-98. PubMed ID: 19999646
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Drug-review deadlines and safety problems.
    Carpenter D; Zucker EJ; Avorn J
    N Engl J Med; 2008 Mar; 358(13):1354-61. PubMed ID: 18367738
    [TBL] [Abstract][Full Text] [Related]  

  • 8. The FDA and drug safety: a proposal for sweeping changes.
    Furberg CD; Levin AA; Gross PA; Shapiro RS; Strom BL
    Arch Intern Med; 2006 Oct; 166(18):1938-42. PubMed ID: 17030825
    [TBL] [Abstract][Full Text] [Related]  

  • 9. How drugs are developed and approved by the FDA: current process and future directions.
    Ciociola AA; Cohen LB; Kulkarni P;
    Am J Gastroenterol; 2014 May; 109(5):620-3. PubMed ID: 24796999
    [TBL] [Abstract][Full Text] [Related]  

  • 10. The history and contemporary challenges of the US Food and Drug Administration.
    Borchers AT; Hagie F; Keen CL; Gershwin ME
    Clin Ther; 2007 Jan; 29(1):1-16. PubMed ID: 17379043
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2008 Jul; 73(136):40453-63. PubMed ID: 18850678
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Lessons learned from independent central review.
    Ford R; Schwartz L; Dancey J; Dodd LE; Eisenhauer EA; Gwyther S; Rubinstein L; Sargent D; Shankar L; Therasse P; Verweij J
    Eur J Cancer; 2009 Jan; 45(2):268-74. PubMed ID: 19101138
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the US food and drug administration: the class of 2008.
    Moore TJ; Furberg CD
    JAMA Intern Med; 2014 Jan; 174(1):90-5. PubMed ID: 24166236
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999.
    Cross J; Lee H; Westelinck A; Nelson J; Grudzinskas C; Peck C
    Pharmacoepidemiol Drug Saf; 2002 Sep; 11(6):439-46. PubMed ID: 12426927
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Food and Drug Administration requirements for testing and approval of new radiopharmaceuticals.
    Harapanhalli RS
    Semin Nucl Med; 2010 Sep; 40(5):364-84. PubMed ID: 20674596
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.
    Wang Y; Bhattaram AV; Jadhav PR; Lesko LJ; Madabushi R; Powell JR; Qiu W; Sun H; Yim DS; Zheng JJ; Gobburu JV
    J Clin Pharmacol; 2008 Feb; 48(2):146-56. PubMed ID: 18199891
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Finding, evaluating, and managing drug-related risks: approaches taken by the US Food and Drug Administration (FDA).
    Weaver J; Grenade LL; Kwon H; Avigan M
    Dermatol Ther; 2009; 22(3):204-15. PubMed ID: 19453344
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Catalyzing the Critical Path Initiative: FDA's progress in drug development activities.
    Parekh A; Buckman-Garner S; McCune S; ONeill R; Geanacopoulos M; Amur S; Clingman C; Barratt R; Rocca M; Hills I; Woodcock J
    Clin Pharmacol Ther; 2015 Mar; 97(3):221-33. PubMed ID: 25670629
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration.
    Ball R; Horne D; Izurieta H; Sutherland A; Walderhaug M; Hsu H
    Pediatrics; 2011 May; 127 Suppl 1():S31-8. PubMed ID: 21502249
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Innovative strategies for early clinical R&D.
    Butz RF; Morelli G
    IDrugs; 2008 Jan; 11(1):36-41. PubMed ID: 18175261
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 26.