MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....An alternative approach may be used if such approach satisfies the requirements of the.....of each facility involved in the manufacturing of the drug substance and excipients should..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

...When evaluating a bulk drug substance used to treat a less serious illness, FDA will generally be more.....However, for a bulk drug substance used to treat a more serious or life-threatening disease, there may be.....In fact, any person who represents that a compounded drug made with a bulk drug substance that appears on this list..
http://www.fda.gov/ohrms/dockets/98fr/010799b.txt (score=99)

GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS
...The USP also notes that the impurity profile of a drug substance is a description of the.....a substance that is represented as a drug and, when used, becomes an active ingredient or finished dosage.....Related substances are defined as those structurally related to a drug substance such as a..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=97)

WAIS Document Retrieval
...When evaluating a bulk drug substance used to treat a less serious illness, FDA will generally be more.....However, for a bulk drug substance used to treat a more serious or life-threatening disease, there may be.....In fact, any person who represents that a compounded drug made with a bulk drug substance that appears on this list..
http://www.fda.gov/cder/fdama/pclist.txt (score=94)

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.....the potential impact on the biological safety, quality, and purity of the drug substance and/or.....guidance, mAb reagents refers to monoclonal antibodies used as reagents in a drug..
http://www.fda.gov/cber/gdlns/mab032901.pdf (score=77)

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.....A list should be provided of all components in the drug product, including drug substance(s)and other ingredients, with.....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)

Document
...351, 352, 353a, 355, nominated drug substances is limited, number and size of the bulk.....abstracts from reliable medical sources, substance has been used in pharmacy.. relevant.....through the new drug approval process, Academy of Compounding Pharmacists, rigorous and..
http://www.fda.gov/cder/fdama/pclist.pdf (score=92)

Substance
...individual batches of the drug substance used in animal and clinical testing, Drug Substance.....Production of a drug substance, whether by synthesis, fermentation, or isolation, usually.....sodium hydroxide) used to neutralize excess acid in a synthetic reaction mixture would not..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=88)

...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 substance, the analytical procedures.....Starting materials of botanical origin that are used to produce a botanical drug substance should be evaluated for..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=81)

stability guidance -draft
...Drug substance batches used to produce site-specific drug product batches should be clearly.....analytical profiles of batches of the drug substance and drug product used in the preclinical.....this guidance to mean a batch of drug substance or drug product manufactured at the scale..
http://www.fda.gov/cder/guidance/1707dft.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.....pharmacodynamic effects of a substance on physiologic functions in relation to exposure.....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)

GUIDE TO INSPECTIONS OF ORAL SOLID DOSAGE FORMS PRE/POST APPROVAL ISSUES...
...In either case it is important that the firm compare the drug substance used to manufacturer the bio.....For example, micronizing or milling a drug substance and providing greater surface area of the.....This includes facilities used for development batches and to be used for full-scale..
http://www.fda.gov/ora/inspect_ref/igs/solid.html (score=7)

...Other comments declared that dietary supplements are safer than most regularly-used drug.....The petitioner must demonstrate, among other things, that the use of the substance at.....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=7)

FDCAct Chapter II - Definitions
...substance used in food prior to January 1, 1958, through either scientific procedures or experience.....drug intended for human use containing any quantity of any chemicaI substance which is.....4) any substance used in accordance with a sanction or approval granted prior to the enactment of..
http://www.fda.gov/opacom/laws/fdcact/fdcact1.htm (score=5)

ANDAs: Impurities in Drug Substances
...Analytical results should be provided for all batches of the drug substance used for stability testing.....to which a drug substance or drug product should conform to be considered acceptable for its.....The control of residues of solvents used in the manufacturing process for the drug..
http://www.fda.gov/cder/guidance/2452fnl.pdf (score=3)

ANDAs: Impurities in Drug Substances, Guidance Document
...Qualifying impurities found in a drug substance used in an ANDA by a comparison with impurities found in.....Analytical results should be provided for all batches of the drug substance used for stability testing.....A material used in the synthesis of a drug substance that is incorporated as an element into the structure of an..
http://www.fda.gov/cder/guidance/2452fnl.htm (score=3)

Prel. draft List of drugs for Pharmacy Comp
...of bulk drug substances that may be used in pharmacy compounding, it does not specify a process through which.....substance's acute toxicity and other reported toxicities, including mutagenicity.....been used topically as a hemostatic agent to control bleeding, including cervical bleeding..
http://www.fda.gov/cder/fdama/draft4.pdf (score=2)

WAIS Document Retrieval
...Such studies should normally be conducted on the drug product or drug substance containing the degradation.....This guideline also does not address the regulation of drug products used during the clinical research.....Safety studies should provide a comparison of results of safety testing of the drug product or drug substance..
http://www.fda.gov/cder/guidance/ichq3b.htm (score=2)

ICH; Guidance for Industry: Q3A Impurities in New Drug Substances
...A material used in the synthesis of a new drug substance that is incorporated as an element into the structure of an.....A substance other than a starting material, intermediate, or solvent that is used in the manufacture of a new drug.....Any component of the new drug substance that is not the chemical entity defined as the new drug..
http://www.fda.gov/cber/gdlns/ichq3a.htm (score=2)

Guidance for Industry: Q3A Impurities in New Drug Substances
...with raw materials that could contribute to the impurity profile of the new drug substance, and.....Differences in the analytical procedures used during development and those proposed for.....the response factors of a drug substance and the relevant impurity are not close, this practice..
http://www.fda.gov/cber/gdlns/ichq3a.pdf (score=2)

Las Vegas Injury Lawyer