MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....manufacturing, processing, packaging, controls, stability testing, or labeling operations.....with characteristics unique to the design, will present challenges in developing..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Guidance- Content & Format CMC for Vaccine & Related Product
...A description should be provided of the potency assay for the drug product.Information should be.....the evidence derived from validation studies which assures that product identity, purity, potency, and stability is preserved for.....This guidance document represents FDA's current thinking on the content and format of the..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=64)

IND content and format for Phase 1 studies
...As clinical development of a drug product proceeds,sponsors should discuss the manufacturing.....Flow diagrams are suggested as the usual,most effective, presentations of this information.....methods used to monitor the stability of the drug..product packaged in the proposed..
http://www.fda.gov/cder/guidance/phase1.pdf (score=52)

Selected Guidance Documents Applicable to Combination Products
...Content of Investigational New Drug Applications for Phase I Studies of Drugs Including Well Characterized, Therapeutic.....Availability of Information Given to Advisory Committee Members in Connection with CDRH.....As an aid to sponsors seeking to develop a combination product, the Office of Combination..
http://www.fda.gov/oc/combination/guidance.html (score=25)

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