MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....discuss significant departures from the approaches outlined in this guidance with the.....For MDI and DPI drug products, certain studies should be performed to determine..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug.....used if such approach satisfies the requirements of the applicable statutes and.....errors and ensure that appropriate corrective action is taken to prevent their recurrence..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=99)

GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS
...a substance that is represented as a drug and, when used, becomes an active ingredient or finished dosage.....The producer of BPCs must recognize the need for appropriate evaluation, using appropriate standards and/or test.....The BPC used to manufacture commercial batches must not significantly differ from that..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=97)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Documents produced for others, where appropriate, can be used to provide the documentation of compliance with.....When the receiving facility disposes of the recalled drug, the PET drug producer should obtain a signed.....Equipment used in the production, processing, or packaging of a PET drug product should be appropriate for the..
http://www.fda.gov/cder/guidance/4259dft.htm (score=95)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...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.....written procedures for appropriate cleaning, maintenance, and sanitization of equipment..
http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0324-gdl0001.pdf (score=87)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...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.....written procedures for appropriate cleaning, maintenance, and sanitization of equipment..
http://www.fda.gov/cber/gdlns/bioplant.pdf (score=87)

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...that of previous trials used to determine historical evidence of sensitivity to drug.....Each type of control group is appropriate in some circumstances, but none is usable or.....substantial accumulation of active drug resulting from a long half life of parent drug or..
http://www.fda.gov/cder/guidance/4155fnl.pdf (score=83)

Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug...
...2 The term drug substance, which is used throughout the text, is intended to include biological products as defined.....impurities during purification of the mAb may be appropriate under certain circumstances.....guidance, mAb reagents refers to monoclonal antibodies used as reagents in a drug..
http://www.fda.gov/cber/gdlns/mab032901.pdf (score=77)

Guidance for Industry: Developing Medical Imaging Drug and Biological...
...However, if a radioactive drug is used for immediate therapeutic, diagnostic, or similar purposes.....planning appropriate safety and dosimetry evaluations of diagnostic radiopharmaceuticals.....safety and effectiveness of the drug in humans, or if the radioactive drug has a..
http://www.fda.gov/cber/gdlns/medimagesaf.pdf (score=75)

PTC in Manufacture and Testing of Monoclonal Antibody Products for Human Use
...commonly used in conjunction with mAb for ex vivo manipulations of cellular products.....entity or is produced by a novel process, and when drug development plans are unusually.....appropriate, immunoglobulin fragments and recombinant proteins derived from..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=99)

Guidance for Industry
...However, if a radioactive drug is used for immediate therapeutic, diagnostic, or similar purpose.....Because of potential toxicities, this approach may not be appropriate for some drugs nor.....safety and effectiveness of the drug in humans, or if the radioactive drug has a pharmacological effect in the body,an IND is..
http://www.fda.gov/cder/guidance/5742prt3.pdf (score=99)

...The areas used for final fill of drug products should follow the recommendations provided in the "Guidelines on.....Such data can be useful in choosing appropriate potency assays, as well as in evaluating.....Plasma may be used instead of serum, provided that the anticoagulant used does not affect..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=95)

Guidance- Content & Format CMC for Vaccine & Related Product
...and derivatives, or glycolipids, used in purification or production of the drug substance,should be described in detail, including.....appropriate quality and purity of the starting materials, including the seed organisms.....same areas used to produce the drug substance that is the subject of this application..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=93)

Guidance for Industry: Manufacturing, Processing, or Holding Active...
...should be comparable to the impurity profile of the API batches used in drug safety and.....procedures should also cover appropriate sampling and retesting of any materials used in.....Once drug development reaches the stage where the API is produced for use in drug products..
http://www.fda.gov/cder/guidance/1289dft.pdf (score=91)

ICH: Guidance on Viral Safety Eveluation of Biotechnology Products Derived...
...used in the context of the understanding of the biology of the virus and the nature of the.....5 As appropriate for cell lines which are known to have been infected by such agents.6 For.....Food and Drug Administration, AGENCY: Food and Drug Administration, Clearance Officer..
http://www.fda.gov/cber/gdlns/virsafe.pdf (score=87)

Substance
...individual batches of the drug substance used in animal and clinical testing, Drug.....Precautions, including animal safety testing when appropriate, to detect, identify, and.....addresses new drug substances manufactured by chemical synthesis, by fermentation, or by..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=83)

...To ensure that a botanical drug product used in clinical trials is of consistently good quality, and.....If questions arise during any stage of the clinical development of a botanical drug, sponsors are encouraged to consult the appropriate.....A chemical constituent of a botanical raw material, drug substance, or drug product that is used for identification and/or quality..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=81)

Pediatric Rule
...In the development of a new drug or biological product, decisions about appropriate.....that are dangerous to health when used in the manner prescribed, recommended, or suggested.....inadequate dosage or regimen, prescribed a less effective drug, or did not prescribe a drug, due to the physician's..
http://www.fda.gov/cder/guidance/pedrule.pdf (score=81)

stability guidance -draft
...include results from microbial challenge studies performed on the drug product at.....and the test methods used to monitor the stability of the drug substance and preliminary.....appropriate for a drug product with respect to the likelihood that such a design would..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=77)

...Other comments declared that dietary supplements are safer than most regularly-used drug.....A few comments objected to the statement that a dietary supplement bearing an appropriate.....The agency notes that for health claims to be used on conventional foods, an interested..
http://www.fda.gov/OHRMS/DOCKETS/98fr/010600a.txt (score=0)

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