MDI and DPI Drug Products
...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.....recommended for inclusion in the application regarding the components, manufacturing..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Document
...Food and Drug Administration, Rockville Pike, suite 200N, Rockville, factual information.....this proposed rule on or before April 18, throughout the lifetime of the product. issuance.....apply to the drug or device components of.. confidential commercial information where such..
http://www.fda.gov/OHRMS/DOCKETS/98fr/011801b.pdf (score=66)

Jurisdictional Update: Metered Dose Inhalers, Spacers and Other Accessories
...Therefore, replacement actuators have been determined to be device components of combination.....Based on FDA’s determination that the primary mode of action of the combination product is attributable to its drug.....Therefore, dose counters frequently have been determined to be device components of combination..
http://www.fda.gov/oc/combination/mdiupdate.html (score=56)

FR 9/30/97 Natural Rubber-Containing Medical Devices; User Labeling
...Combination products that have device and drug components but are regulated under drug premarket approval.....The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic.....At this time, the agency anticipates that the Drug/Device Intercenter Agreement will be amended..
http://www.fda.gov/cdrh/dsma/fr93097.html (score=48)

file:///C|/Daily/1125fda.txt
...23 drug or the device, or perhaps to both components, 24 and the labeling may not be the same between.....22 right now the way it works is the product comes in, 23 specifically, I work with a.....12 the drug or the device, so again, the typical NDA, 13 aNDA process for the drug or the contrast..
http://www.fda.gov/oc/ombudsman/transcript112502.pdf (score=39)

Transcript of the Public Hearing on November 25, 2002 on FDA Regulation of...
...Classification or designation, is the product a drug, device, or biologic, a single entity product, or is.....We all recognize that the combination of two components, such as a drug and a device.....Irrespective of the premarket review mechanism, a drug-device combination product application would consist of..
http://www.fda.gov/oc/combination/transcript112502.html (score=38)

FDA'S OFFICE OF COMBINATION PRODUCTS:ROLES, PROGRESS&CHALLENGES
...Yet another type of drug and device combination may be one in which the drug and device components are.....A drug-device combination product, for example, may be comprised of a drug coated on a device, or a drug packaged.....new drug product exclusivity, orphan product designation, or proprietary data protection when..
http://www.fda.gov/oc/combination/jmdr2005.html (score=36)

Process Validation
...In one case, a firm used such water to make a topical drug product solution which, in view of.....control measures shall be established to assure that the design basis for the device, components.....In some cases, a drug product or medical device may be manufactured individually or on a one-time basis. The..
http://www.fda.gov/cder/guidance/pv.htm (score=31)

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.....In the case of device-metered DPIs, the particle size distribution of the drug substance.....Furthermore, modification or alteration of these products due to changes in components of the drug product or..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=30)

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.....Additionally, dimensional measurements of the critical components of the device should be held to very tight.....Furthermore, modification or alteration of these products due to changes in components of the drug product or..
http://www.fda.gov/cder/guidance/2180dft.htm (score=30)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...address during the investigation of a new animal drug and preparation of an.....field trials will be obtained prior to submission of a product application, APHIS/BRS will.....the purified drug substance is held prior to further processing, a description of the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0324-gdl0001.pdf (score=28)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...address during the investigation of a new animal drug and preparation of an.....field trials will be obtained prior to submission of a product application, APHIS/BRS will.....the purified drug substance is held prior to further processing, a description of the..
http://www.fda.gov/cber/gdlns/bioplant.pdf (score=28)

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 device regulations.....AdvaMed noted that in combination products that have separate components, historically the.....the drug substance was subject to drug GMPs while the drug-device combination product was subject to the quality..
http://www.fda.gov/oc/combination/workshop070803.html (score=28)

Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996
...FDA suggests that, to identify a drug or device, the exporter describe in the notification the.....drug components that are not approved for use in marketed products in the United States, but.....device components, parts, accessories, or other articles of a device not approved in the United..
http://www.fda.gov/opacom/fedregister/frexport.html (score=26)

FR Doc 05-16527
...The drug and biological product components may be copackaged or are provided separately but cross-labeled for use.....A drug-device combination product with a device PMOA, where the device is regulated by CBER.....CDER Though the product has a device mode of action, the product's primary mode of action is..
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-16527.htm (score=26)

Combination Products: Challenges and Progress
...Yet another type of drug and device combination is one in which the drug and device components are.....new drug product exclusivity, orphan product designa­tion or proprietary data protection when.....A drug-device combination product, for example, may be comprised of a drug coated on a device, or a drug packaged with a..
http://www.fda.gov/oc/combination/aug05_09_combinations.html (score=26)

Guidance for Reviewers - Instructions and Template for Chemistry,...
...If the reagent is regulated as a biologic, drug, or device, you should consider whether a.....indicate whether the product or components are likely to remain stable for the duration of the.....and complexity inherent in the components used to generate the final product, such as the..
http://www.fda.gov/cber/gdlns/cmcsomcell.pdf (score=26)

Guidance for FDA Review Staff and Sponsors: Content and Review of...
...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.....appropriate method of assuring that the process consistently produces a sterile product. Refer to the "Guideline on Sterile Drug..
http://www.fda.gov/cber/gdlns/gtindcmc.pdf (score=26)

...Release of the drug from the drug product produces droplet or drug particle sizes and distribution patterns.....Complete batch records, including batch numbers of device components used in the batches, would.....From a product quality perspective, the critical issues are release of drug substance from drug product and..
http://www.fda.gov/cder/guidance/5383DFT.doc (score=26)

Draft Guidance for Industry - Drugs, Biologics & Medical Devices Derived...
...If you are planning to produce a non-protein drug product for human use in a bioengineered.....Virus-mediated transient transfection systems, in their simplest form, employ two.....Waste material from the manufacture of human drug and biological products, or animal drugs..
http://www.fda.gov/cber/gdlns/bioplant.htm (score=26)

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