MDI and DPI Drug Products
...manufacturing, processing, packaging, controls, stability testing, or labeling operations.....The guidance sets forth information that should be provided to ensure continuing drug.....DPIs, the formulation, and the device with all of its parts including any protective..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...information on the stability of the final product and any in-process material at each.....conditions and verification of its stability under the conditions described should be.....field trials will be obtained prior to submission of a product application, APHIS/BRS will..
http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0324-gdl0001.pdf (score=62)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...information on the stability of the final product and any in-process material at each.....conditions and verification of its stability under the conditions described should be.....field trials will be obtained prior to submission of a product application, APHIS/BRS will..
http://www.fda.gov/cber/gdlns/bioplant.pdf (score=62)

Draft Guidance for FDA Review Staff and Sponsors - Content and Review of...
...Describe any stability testing performed on the product during the holding steps, such as cryopreservation of cells, holds.....Document in the review basic information concerning the device, such as the device name, vendor or source.....Some of these challenges include the variability and complexity inherent in the components..
http://www.fda.gov/cber/gdlns/gtindcmc.htm (score=44)

Guidance for FDA Review Staff and Sponsors: Content and Review of...
...information, including your justification of the assays used to indicate product stability.....components used during the manufacture of the gene therapy product, such as vector, cells.....describe the use of any cell selection device or separation device, including density gradients, magnetic beads..
http://www.fda.gov/cber/gdlns/gtindcmc.pdf (score=44)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...The performance of the valve and its compatibility with other drug product components should be.....Such a correlation may obviate the need to evaluate leachables in the drug product formulation in future routine stability.....Current designs include pre-metered and device-metered DPIs, both of which can be driven..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=43)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...A complete description of the source and composition of all device components should be provided.....Such a correlation may obviate the need to evaluate leachables in the drug product formulation in future routine stability.....The performance of the valve and its compatibility with other drug product components should be..
http://www.fda.gov/cder/guidance/2180dft.htm (score=43)

Guidance for Reviewers - Instructions and Template for Chemistry,...
...indicate whether the product or components are likely to remain stable for the duration of the.....You should assess the sponsor's plans for determining the stability of the final product.....If the reagent is regulated as a biologic, drug, or device, you should consider whether a..
http://www.fda.gov/cber/gdlns/cmcsomcell.pdf (score=42)

Draft Guidance for Industry - Drugs, Biologics & Medical Devices Derived...
...stability of the product, ability to support growth of microorganisms, residual soil content, presence of.....Virus-mediated transient transfection systems, in their simplest form, employ two.....Because microbiological contaminants can have an adverse effect on product safety, quality, and stability, we recommend..
http://www.fda.gov/cber/gdlns/bioplant.htm (score=42)

Draft Guidance for Reviewers: Instructions and Template for Chemistry,...
...You also should document basic information concerning the device components of the combination product, such as the device name.....You should assess the sponsor’s plans for determining the stability of the final product.....You also should document any stability testing performed on the product during the holding..
http://www.fda.gov/cber/gdlns/cmcsomcell.htm (score=42)

Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical...
...Allison recommended that the drug regulations should apply to the drug portions of the product, and the.....Considerations for drug chemistry and stability evaluations for novel drug-device.....AdvaMed noted that in combination products that have separate components, historically the..
http://www.fda.gov/oc/combination/workshop070803.html (score=25)

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