MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....formulation, moisture level, consistency of filling operation, particle size distribution.....The guidance sets forth information that should be provided to ensure continuing drug..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

WAIS Document Retrieval
...Background Persistent problems with drug product mislabeling and subsequent recalls in the.....FDA found that stacks of labeling of similar size, shape, and color could easily be.....Cut labeling for individual drug products is commonly placed in separate stacks before..
http://www.fda.gov/cder/dmpq/frpr7297.htm (score=96)

þÿ
...of drug effect size can be well supported by reference to the results of previous studies.....smallest effect size that the active drug would be reliably expected to have is only.....substantial accumulation of active drug resulting from a long half life of parent drug or..
http://www.fda.gov/cder/guidance/4155fnl.pdf (score=95)

Document
...As a rule, clinical trials supporting drug development. sensitivity of the overall.....treatment effects nor unblinding of data and, sample size for the trial. guideline and the.....Food and Drug Administration, 5600 Fishers Lane, Rockville, MD.. notice gave interested..
http://www.fda.gov/cder/guidance/91698.pdf (score=94)

OTC Labeling:  Questions and Answers
...Homeopathic drug products are subject to the same labeling provisions of the Food, Drug, and Cosmetic Act as other drug.....5-point minimum type size is not readable, and another study presented information that 6.....Certain OTC drug products are not required to use the new format for 6 years, although..
http://www.fda.gov/cder/otc/label/quesanswers.htm (score=94)

Guidance for Industry
...Direct inoculation into the drug formulation provides an assessment of the effect of drug.....of no more than 3520 in a size range of 0.5 micron and larger when counted at.....when finalized, will replace the 1987 Industry Guideline on Sterile Drug Products Produced..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=94)

GUIDE TO INSPECTIONS OF TOPICAL DRUG PRODUCTS
...Particle size can also affect the activity of the drug substance because the smaller the particle size the greater its surface area.....Uniformity and particle size are particularly significant where the drug substance is.....The subjects covered in the guide are generally applicable to all forms of topical drug..
http://www.fda.gov/ora/inspect_ref/igs/topic.html (score=94)

Guidance for Industry
...Direct inoculation into the drug formulation provides an assessment of the effect of drug.....of no more than 3520 in a size range of 0.5 micron and larger when counted at.....when finalized, will replace the 1987 Industry Guideline on Sterile Drug Products Produced..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=93)

GUIDE TO INSPECTIONS OF ORAL SOLID DOSAGE FORMS PRE/POST APPROVAL ISSUES...
...For example, in a filed process it was determined that particle size would have no effect on drug absorption and.....The size and even the type of granule can affect the pore size in a tablet and have an.....Characterization of the chemical and physical properties of the drug substance is one of..
http://www.fda.gov/ora/inspect_ref/igs/solid.html (score=92)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...Even slight changes in the formulation, drug substance particle size, valve, or actuator can have a major effect.....Other important properties of the drug substance may include particle size distribution, particle morphology, solvates and.....In addition, careful control of the impurities and degradation products in the drug substance and drug..
http://www.fda.gov/cder/fdama/difconc.htm (score=92)

Product Name Placement, Size, and Prominence in Advertising an
...This print size requirement relates to actual size, not point size, of upper case and.....and advertising for all prescription human and animal drug and biological products is.....drug products that contain either a single active ingredient or two or more active..
http://www.fda.gov/cder/guidance/1955dft.pdf (score=92)

þÿ
...This draft guidance, when finalized, will represent the Food and Drug Administration=s.....especially when the labeling differs because of the size or design of the individual.....1This guidance has been prepared by the Division of Over-the-Counter Drug Products in the..
http://www.fda.gov/cder/guidance/3437dft.pdf (score=92)

Issued 03-12-1999 Guidance Prod Name Placement, Size & Prominence in Advert...
...This print size requirement relates to actual size, not point size, of upper case and.....and advertising for all prescription human and animal drug and biological products is.....drug products that contain either a single active ingredient or two or more active..
http://www.fda.gov/cber/gdlns/adprodft.pdf (score=91)

FDA IND, NDA, ANDA, or Drug Master File Binders
...As of June 10, 1997, FDA no longer provides IND, NDA, ANDA or Drug Master Files.....Sample is SMALLER in print (FONT) size than actual cover. Printing MUST match lay-out of.....FDA IND, NDA, ANDA, or Drug Master File Binders .. Effective, Wednesday, April 1, 1998..
http://www.fda.gov/cder/ddms/binders.htm (score=90)

...Also, we need to keep in mind when we look at these endpoints that there are drug-drug.....Sridhara will review for you shortly, the sample size needed for a non-inferiority study.....Should we conduct studies where the new drug product X is superior to letrozole or drug X..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3782t1_01.htm (score=90)

The New Food Label
...Under regulations from the Food and Drug Administration of the Department of Health and.....However, unlike in the past, when the serving size was up to the discretion of the food.....The serving size of products that come in discrete units, such as cookies, candy bars, and..
http://www.fda.gov/opacom/backgrounders/foodlabel/newlabel.html (score=89)

Substance
...individual batches of the drug substance used in animal and clinical testing, Drug.....less than 5 milligrams per milliliter) both the typical original particle size distribution and the particle size.....addresses new drug substances manufactured by chemical synthesis, by fermentation, or by..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=89)

Guidance for Industry: Manufacturing, Processing, or Holding Active...
...Once drug development reaches the stage where the API is produced for use in drug products.....intermediates should be of suitable design, size, construction and location to facilitate.....requirements or standards regarding APIs within the context of new drug application..
http://www.fda.gov/cder/guidance/1289dft.pdf (score=89)

general considerations (2867fnl)
...regulatory submissions in electronic format to the Center for Drug Evaluation and.....discourage the use of grayscale or color because of file size. After scanning,avoid.....Therefore,dataset files should be organized so that their size is generally less than 25..
http://www.fda.gov/cder/guidance/2867fnl.pdf (score=88)

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