56 Contains Nonbinding Recommendations Guidance for Industry1 Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or...
Guidance for Industry 1 1 Reference Product Exclusivity for Biological Products 2 Filed Under 351(a) of the PHS Act 3 4 5 This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s or the 6 Agency’s) current thinking on this topic. It does not creat...
The updated guidance has only been in circulation for a short while and needs to be further assessed and reviewed by industry. Although, no longer technically at draft stage, comments can still be passed to FDA via the usual routes, and there are already training courses and seminars where th...
We (FDA) recommend that you use this guidance as a companion to otherFDA guidance documents describing the chemistry, manufacturing, and control (CMC) information submitted and reviewed in an IND application for phase 1 clini...
Guidance for Industry and FDA Regulation of Medical Devices : Background Information for International OfficialsServices, Human
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays Document issued on January 10, 2007 For questions regarding this document contact Nina Hunter at 301-796-6171 or by email atnina.hunter@fda.hhs.gov....
Guidance for Industry1 Rheumatoid Arthritis: Developing Drug Products for Treatment This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not opera...
美国FDA指导原则 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays.docx,Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: T
If you need clarification on the applicability of this guidance to a specific clinical trial, contact the appropriate FDA Center with responsibility for review of the IND. 本指南适用于1期研究性药物,无论它们是在小型或大型环境中生产,因为1期临床试验(21 CFR 312.21(a))通常是为了评估特定药物或生物制...
Administration 5600FishersLane Rockville,MD20857 (Tel)301-827-4573 http://.fda.gov/cder/guidance/index.htm or OfficeofCommunication,Trainingand ManufacturersAssistance,HFM-40 CenterforBiologicsEvaluationandResearch FoodandDrugAdministration 1401RockvillePike,Rockville,MD20852-1448 http://.fda.gov/cber/...