The Orphan Drug Regulations
...If sponsors provide evidence to demonstrate that an improvement in purity will cause a drug to meet one or more of the.....reasonable criteria for identifying drugs as different for purposes of determining orphan.....In addition, a sponsor of a drug that is otherwise the same drug as an already approved orphan drug may seek and obtain..
http://www.fda.gov/orphan/odreg.htm (score=100)

Document
...protocol use of the investigational drug, 20857, 301­827­4460. particularly in children.....basis of criteria established by the Secretary. Thomas A. Scully, FDA is announcing the.....Food and Drug Administration, New York, New Jersey, the District of.. homestead of `modest..
http://www.fda.gov/OHRMS/DOCKETS/98fr/031802a.pdf (score=100)

...The following represent the general criteria that will apply in making device/drug.....A device that serves as a container for a drug or a device that is a drug delivery system attached to the drug.....Section VIII provides the general criteria that CDRH and CDER will apply in reaching..
http://www.fda.gov/oc/ombudsman/drug-dev.htm (score=100)

MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....The guidance sets forth information that should be provided to ensure continuing drug.....criteria that are numerical limits, ranges or other criteria for the tests described..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=35)

...Because many of these claims would previously have been covered by the drug definition in.....The regulations also establish criteria for determining when a statement about a dietary.....those that have not met the requirements for health claim authorization or new drug..
http://www.fda.gov/OHRMS/DOCKETS/98fr/010600a.txt (score=34)

/a/content.30891
...using the criteria, what we have defined as the f2 criteria, 22.. which is a simulated.....rate and extent of drug absorption, its pharmacokinetics, 16.. pharmacodynamics, and the.....trends in technology and applications in drug development, 9.. to modeling and simulation..
http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3657t2.pdf (score=34)

Evaluation of Written Prescription Information Provided in Community...
...While there were some variation among study drugs for Criteria 1-5, there were few drug differences for.....Level of adherence to criteria varied across the eight criteria, with the highest means.....Since long drug names may result in overestimation of reading skill required3, drug names..
http://www.fda.gov/cder/reports/prescriptionInfo/default.htm (score=33)

FR Notice - Human Cells, Tissues, and Cellular and Tissue-Based Products;...
...Our ability to regulate an HCT/P as a drug, device, and/or biological product derives from.....HCT/P's that do not meet FDA's criteria set forth in part 1271 for regulation solely under.....The section now also clarifies that the referenced drug and device regulations apply if..
http://www.fda.gov/cber/rules/frtisreg011901.htm (score=33)

FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based...
...discussion through public meetings, involving an investigational drug or.. Peripheral and.....that the HCT/P meets all other criteria.. In addition, for certain ethnic groups, comply.....contains cross-references to those drug.. be warranted. and efficacy and protect the..
http://www.fda.gov/cber/rules/frtisreg011901.pdf (score=32)

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...the drug, that may occur as part of the pharmacological action of the drug or may be.....Establish criteria for the development and distribution of written prescription medicine.....situation in which drug samples are given to a patient, oral communication about the drug..
http://www.fda.gov/cder/Offices/ODS/keystone.pdf (score=32)

...We found two 7 instances last year, two different drug products 8 and I will call them drug C and.....Also, that the point 25 estimate criteria be added to the criteria because, 72 1 in fact, all products will pass.....1 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH ADVISORY..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4034T2.DOC (score=32)

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.....including the analytical procedures that will be used, and acceptance criteria that will.....the drug substance, drug product, and/or, if appropriate, the intermediate, in-process..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=32)

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.....including the analytical procedures that will be used, and acceptance criteria that will.....the drug substance, drug product, and/or, if appropriate, the intermediate, in-process..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=32)

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