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.....establish a set of criteria to which a drug substance or drug product should conform using..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....used if such approach satisfies the requirements of the applicable statutes and.....or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=99)

GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS
...It would be unrealistic to expect drug product GMP concepts to apply to the production of these.....a substance that is represented as a drug and, when used, becomes an active ingredient or finished dosage.....It has been demonstrated that impurities in a finished drug product can cause degradation and..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=97)

Guidance for Industry
...However, if a radioactive drug is used for immediate therapeutic, diagnostic, or similar purpose.....In studies that compare the effects of a test agent with another drug, biological product.....possible, the formulation that will be used for marketing should be used during phase 2..
http://www.fda.gov/cder/guidance/5742prt3.pdf (score=99)

PTC in Manufacture and Testing of Monoclonal Antibody Products for Human Use
...These trials cannot be used by themselves to support licensure of a product.Studies conducted in normal volunteers are not included in.....entity or is produced by a novel process, and when drug development plans are unusually.....separate product lots during drug development to demonstrate that a safe and effective..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=99)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Critical activities in the production and testing of a PET drug product that expose the PET drug product or the sterile surface.....Equipment used in the production, processing, or packaging of a PET drug product should be.....An alternative approach may be used if such approach satisfies the requirements of the..
http://www.fda.gov/cder/guidance/4259dft.htm (score=95)

...only a limited characterization of the processes used to prepare the product for their ability to remove.....Sponsors should study a number of separate product lots during drug development to demonstrate that a safe and.....The areas used for final fill of drug products should follow the recommendations provided in the "Guidelines on..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=95)

Document
...number in this manner would, code requirement, and we consider drug doses of the drug.....drugs are used in hospitals, so bar codes errors involving radiopharmaceuticals, bar codes.....manufacturer, product, and package. prevent the introduction, transmission, drug product..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.pdf (score=93)

Guidance- Content & Format CMC for Vaccine & Related Product
...A list should be provided of all components in the drug product, including drug substance(s)and.....same areas used to produce the drug substance that is the subject of this application.....This section should contain information on the final drug product including all drug substances..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=93)

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=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.....field trials will be obtained prior to submission of a product application, APHIS/BRS will..
http://www.fda.gov/cber/gdlns/bioplant.pdf (score=87)

ICH: Guidance on Viral Safety Eveluation of Biotechnology Products Derived...
...and for the removal of virus from product, acceptable level of safety in the final product.....used in the context of the understanding of the biology of the virus and the nature of the.....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.....relation to the amount of crude product, whether it is filtered while hot, whether a.....addresses new drug substances manufactured by chemical synthesis, by fermentation, or by..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=83)

Pediatric Rule
...In the development of a new drug or biological product, decisions about appropriate populations to study and.....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)

...To ensure that a botanical drug product used in clinical trials is of consistently good quality, and.....A chemical constituent of a botanical raw material, drug substance, or drug product that is used for identification and/or quality.....The quality control tests performed on each batch of drug product, the analytical procedures..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=81)

stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale typically encountered.....and the test methods used to monitor the stability of the drug product packaged in the.....and the test methods used to monitor the stability of the drug substance and preliminary..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=77)

FDA Enforcement Report
...Phentermine HCl Capsules, USP, 30 mg, in 100, 1,000 capsule bottles, an Rx drug used in weight.....Ultra-Technekow FM Technetium TC99M Generator, an Rx product used as a radiopharmaceutical.....The product was not manufactured in accordance with Abbreviated New Drug application..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00010.html (score=15)

FDA Enforcement Report
...tablets, USP in 100 and 1000 tablet bottles, an Rx drug used as a diuretic, under the following.....Subpotency of the isopropyl alcohol product and current good manufacturing practice.....and Alcohol 5%, an Rx drug Schedule III oral liquid drug used for the symptomatic relief of cough and nasal congestion, under..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00057.html (score=13)

FDA Issues Nationwide Alert for Liqiang 4 Due to Potential Health Risk
...Glyburide is a drug used to lower blood sugar, and is safe and effective when used as labeled.....The product is manufactured by Liqiang Research Institute, China, and marketed throughout.....The product is sold as part of a shrink-wrapped two bottle set. One of the 90 capsule..
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01363.html (score=7)

FDA Enforcement Report
...Multi Vit Drops, in 50 ml bottles, an OTC product used for the supplementation of the diet for.....025% Triamcinolone Acetonide, 15 gram and 80 gram tubes, an Rx drug, used for the relief of the.....Ingredient statement on label incorrectly indicates 50 mg hydrocortisone per gram, when..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00168.html (score=7)

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