Guidance for Industry . Clinical Pharmacology Data . to Support a Demonstration of Biosimilarity to a Reference Product. DRAFT GUIDANCE. This guidance document is ...
7 8 This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s or 9 Agency’s) current thinking on this topic ...
When SOVALDI is used in combination with ribavirin or peginterferon alfa/ribavirin, women of childbearing potential and their male partners must use two forms of ... Down
When SOVALDI is used in combination with ribavirin or peginterferon alfa/ribavirin, women of childbearing potential and their male partners must use two forms of ...www.accessdata.fda.gov/drugsatfda_docs/label/2013/204671s000lbl.pdf
Page 2 -Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device ...www.accessdata.fda.gov/cdrh_docs/pdf7/K071822.pdf
FDA Provides Oversight of Clinical Trials Why? • To protect the rights, safety, and welfare of subjects involved in FDA-regulated clinical trialspremier-research.com/images/uploads/Managing_FDA_Inspections.pdf
(A2LA Cert. No. 1698.05) 02/01/2013 Page 1 of 2 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 FOOD SAFETY NET SERVICES, LLC 60 Chamisa Road Suite 201www.a2la.org/scopepdf/1698-05.pdf