MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....An alternative approach may be used if such approach satisfies the requirements of the.....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Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...including the data from the material used to prepare clinical/pre-clinical lots and.....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..
http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0324-gdl0001.pdf (score=71)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...including the data from the material used to prepare clinical/pre-clinical lots and.....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..
http://www.fda.gov/cber/gdlns/bioplant.pdf (score=71)

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.....Device container vials with dry natural rubber stoppers, when used in combination with a drug product, may be subject to.....The agency intends to require that all combination products that contain natural rubber device..
http://www.fda.gov/cdrh/dsma/fr93097.html (score=12)

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.....The specific valve used in each MDI drug product should be carefully selected considering.....In the case of device-metered DPIs, the particle size distribution of the drug substance..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=5)

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.....The specific valve used in each MDI drug product should be carefully selected considering..
http://www.fda.gov/cder/guidance/2180dft.htm (score=5)

Guidance for Reviewers - Instructions and Template for Chemistry,...
...and complexity inherent in the components used to generate the final product, such as the source of.....If the reagent is regulated as a biologic, drug, or device, you should consider whether a.....Include three to four words that can be used to identify the product, indication, and important reagent or..
http://www.fda.gov/cber/gdlns/cmcsomcell.pdf (score=4)

Guidance for FDA Review Staff and Sponsors: Content and Review of...
...Include three to four words that can be used to identify the product, indication, and important reagent or.....components used during the manufacture of the gene therapy product, such as vector, cells.....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=4)

...Complete batch records, including batch numbers of device components used in the batches, would accompany.....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 or..
http://www.fda.gov/cder/guidance/5383DFT.doc (score=4)

Draft Guidance for Reviewers: Instructions and Template for Chemistry,...
...You should ask the CDER consult reviewer to identify concerns with how the drug will be used in the combination product and.....You also should document basic information concerning the device components of the combination.....You should determine the regulatory status of the drug or device either by contacting the RPM or..
http://www.fda.gov/cber/gdlns/cmcsomcell.htm (score=4)

Draft Guidance for FDA Review Staff and Sponsors - Content and Review of...
...Some of these challenges include the variability and complexity inherent in the components used to generate the final product.....If the reagent is regulated as a drug or device, consider whether a consultative review should be.....Include all of the components used during the manufacture of the gene therapy product, such as vector..
http://www.fda.gov/cber/gdlns/gtindcmc.htm (score=4)

BA/BE studies for Nasal Aerosols and Nasal Sprays for Local Ac
...information that pertains to the identity, strength,quality, purity, and potency of a drug.....functional equivalence of products as a result of differences in the device components of.....Alternatively, a PK batch similar to a batch used in a pivotal clinical trial may be used..
http://www.fda.gov/cder/guidance/2070dft.pdf (score=4)

Las Vegas Injury Lawyer