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.....SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant..
http://www.fda.gov/medwatch/SAFETY/2004/feb04.htm (score=100)

MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....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..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=84)

Packaging
...If a medicine dropper is incorporated as an integral part of the drug container or closure, pertinent information on materials.....If they do, adequate information to justify the use of the container system in combination with the drug product should be.....If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier..
http://www.fda.gov/cder/guidance/package.htm (score=84)

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=84)

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...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/cder/guidance/4828fnl.PDF (score=82)

Format and Content for the CMC Section of an Annual Report
...regulations have exhibited wide variability from firm to firm, and at times the.....To describe the information requested by the Center for Drug Evaluation and Research(CDER) in an Annual Report to a New Drug.....during the reporting period, including immediate container labels, carton..labeling, and..
http://www.fda.gov/cder/guidance/cmc1.pdf (score=80)

Consistent Container Information in an Abbreviated Application
...The stability section only describes the container as made from"HDPE resin with a metal.....To ensure that generic drug firms provide consistent descriptions of container.....In addition to information on the..batch number and strength of the drug product used, the..
http://www.fda.gov/cder/mapp/5225-2.pdf (score=80)

stability guidance -draft
...Communications Management, Drug Information Branch, HFD-210, 5600 Fishers Lane, Rockville.....The date placed on the container/labels of a drug product designating the time during.....Biologics for qualification and quality control information requested for container..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=79)

Microsoft Word - 5320.1.doc
...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.....quality microbiology information in applications submitted in the CTD-Q format. BACKGROUND..
http://www.fda.gov/cder/mapp/5320.1.pdf (score=74)

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.....and Acceptance Criteria for New Drug Substances and New Drug Products:Chemical Substances International Conference..
http://www.fda.gov/cder/mapp/5015-4.pdf (score=74)

Microsoft Word - 5020.1.doc
...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.....quality microbiology information in applications submitted in the CTD-Q format. BACKGROUND..
http://www.fda.gov/cder/mapp/5020.1.pdf (score=74)

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=73)

...For further information on the OTC drug monograph approach to marketing a botanical drug product, sponsors are.....A description of the container/closure in which the botanical drug substance is to be.....However, monitoring representative chemical constituents in a botanical drug can provide valuable information..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=73)

FR Doc 04-4249
...Alternatively, it may be possible to modify the drug's immediate container to accommodate a label bearing a.....The comment explained that information on the drug's concentration and amount could.....For blood and blood components, the proposal would require the use of machine-readable information on the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.htm (score=72)

Guidance for Industry Botanical Drug Products
...For further information on the OTC drug monograph approach to marketing a botanical drug product, sponsors are.....A description of the container/closure in which the botanical drug substance is to be.....22, an IND must contain sufficient information to demonstrate that the drug product is..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=72)

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.....the outside container or wrapper (see 68 the time the drug is administered. at the unit..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.pdf (score=71)

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.....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=70)

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.....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=70)

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...order on the outside container of the retail package and, if determined to be appropriate.....This draft guidance, when finalized, will represent the Food and Drug Administration=s.....types of requests the Agency is likely to grant and on the kinds of information that..
http://www.fda.gov/cder/guidance/3437dft.pdf (score=70)

FDA Chemical and Biological Emergency Response Plan
...The Information Officer handles all media inquiries and coordinates the release of.....The classification and identification of the material from a drum, container, or sample.....Providing sponsors and other stakeholders with guidance on the development of drug and..
http://www.fda.gov/oc/ocm/cbplan.html (score=69)

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