MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....elastomeric, plastic components or coatings of the container and closure system when in.....with characteristics unique to the design, will present challenges in developing..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

þÿ
...18 The applicant and/or drug product manufacturer must establish the reliability of the.....recommends that the drug substance information be included in a master file or incorporated in the.....A description of the container closure system for the drug substance should be provided..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=79)

þÿ
...18 The applicant and/or drug product manufacturer must establish the reliability of the.....recommends that the drug substance information be included in a master file or incorporated in the.....A description of the container closure system for the drug substance should be provided..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=77)

stability guidance -draft
...If testing of the drug product in the immediate container or as marketed is needed, the samples.....when there is a significant body of information on the stability of the drug product and.....Biologics for qualification and quality control information requested for container..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=70)

Packaging
...If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier of a.....If a medicine dropper is incorporated as an integral part of the drug container or closure, pertinent information on materials.....It is also possible for a component of the drug product to migrate through the walls of the..
http://www.fda.gov/cder/guidance/package.htm (score=67)

MedWatch - February 2004 Safety-Related Drug Labeling Changes - Detailed
...The detailed view includes drug products with safety labeling changes to the.....Extensive revisions to the prescribing information, container and carton. Please see prescribing.....Methadone Hydrochloride Injection (click product name to read prescribing information..
http://www.fda.gov/medwatch/SAFETY/2004/feb04.htm (score=62)

FR Doc 04-4249
...For example, if an OTC drug manufacturer made and sold a particular drug product, that drug product would have a.....For blood and blood components, the proposal would require the use of machine-readable information on the.....Additionally, parties that objected to listing a particular OTC drug product or class could..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.htm (score=57)

Microsoft Word - 5320.1.doc
...Description of the Composition of the Drug Product..Description of the drug product composition.....process and validation information for a sterile drug substance is the same as..for a.....Container Closure System..Description of the container-closure system used for the drug..
http://www.fda.gov/cder/mapp/5320.1.pdf (score=55)

Microsoft Word - 5020.1.doc
...Description of the Composition of the Drug Product..Description of the drug product composition.....process and validation information for a sterile drug substance is the same as..for a.....Container Closure System..Description of the container-closure system used for the drug..
http://www.fda.gov/cder/mapp/5020.1.pdf (score=53)

Format and Content for the CMC Section of an Annual Report
...regulations have exhibited wide variability from firm to firm, and at times the.....Regulatory specifications and analytical methods for the drug substance and drug..product should be listed.....during the reporting period, including immediate container labels, carton..labeling, and..
http://www.fda.gov/cder/guidance/cmc1.pdf (score=51)

Guidance- Content & Format CMC for Vaccine & Related Product
...A description should be provided of the potency assay for the drug product.Information should be.....A description of the container and closure system, and its compatibility with the drug.....This section should contain information on the stability of the drug substance and any in..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=50)

Guidance for Industry Botanical Drug Products
...22, an IND must contain sufficient information to demonstrate that the drug product is safe for testing in humans and that the.....A description of the container/closure in which the botanical drug substance is to be.....If existing information on the safety and effectiveness of a botanical drug product is..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=48)

Document
...number in this manner would, code requirement, and we consider drug doses of the drug.....information to be encoded for vaccines, a separate regulatory process for vaccine compared.....manufacturer, product, and package. prevent the introduction, transmission, drug product..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.pdf (score=46)

...22, an IND must contain sufficient information to demonstrate that the drug product is safe for testing in humans and that the.....A description of the container/closure in which the botanical drug substance is to be.....For phase 3 clinical studies of a botanical product, the following information should be provided in meeting the..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=46)

Orange Book Preface
...If this drug product had a 20 ml and 60 ml container approved the two products would be shown.....An Addendum contains drug patent and exclusivity information for the Prescription and OTC Drug Product Lists, and for.....For example, product information labeled as Reserpine, Hydrochlorothiazide and Hydralazine..
http://www.fda.gov/cder/ob/docs/preface/ecpreface.htm (score=34)

Chem Revs. of DMFs for DSIs
...Summarize the data showing that the container/closure system is compatible with the drug.....intended to provide confidential information in support of an application,amendment, or.....If a drug product available for oral use is then submitted as an..ophthalmic product..
http://www.fda.gov/cder/mapp/5015-4.pdf (score=34)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...2 The general term product as used in this guidance means drug substance, drug product, and intermediate, or in.....In the past, applicants have used protocols for container closure system changes, and they.....information required for approval comes from studies not conducted by or for the applicant..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=33)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...2 The general term product as used in this guidance means drug substance, drug product, and intermediate, or in.....In the past, applicants have used protocols for container closure system changes, and they.....information required for approval comes from studies not conducted by or for the applicant..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=30)

Consistent Container Information in an Abbreviated Application
...The stability section only describes the container as made from"HDPE resin with a metal.....batch number and strength of the drug product used, the source of the active drug..substance.....To ensure that generic drug firms provide consistent descriptions of container..information in the..
http://www.fda.gov/cder/mapp/5225-2.pdf (score=29)

Guidance for Industry: Container Closure Systems for Packaging Human Drugs...
...Information on container closure systems used for storage of bulk drug products,other than biologics or.....3 A bulk drug product means finished dosage form that has not yet been packaged into the.....information need to be included in the application? 1 This guidance has been prepared by..
http://www.fda.gov/cber/gdlns/cntanrq&a.pdf (score=28)

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