MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....formulation, moisture level, consistency of filling operation, particle size distribution.....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)

Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....of no more than 3520 in a size range of 0.5 micron and larger when counted at.....terminally sterilized drug product, on the other hand, undergoes a single sterilization process..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=78)

Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....of no more than 3520 in a size range of 0.5 micron and larger when counted at.....terminally sterilized drug product, on the other hand, undergoes a single sterilization process..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=74)

WAIS Document Retrieval
...Background Persistent problems with drug product mislabeling and subsequent recalls in the late.....FDA found that stacks of labeling of similar size, shape, and color could easily be.....Mislabeled drug products may pose a threat to public health, lead to extremely costly..
http://www.fda.gov/cder/dmpq/frpr7297.htm (score=71)

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.....less than 5 milligrams per milliliter) both the typical original particle size distribution and the particle size..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=57)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...To qualify for these statutory exemptions, a compounded drug product must satisfy several.....Even slight changes in the formulation, drug substance particle size, valve, or actuator can have a major effect.....One requirement is that the drug product may only be compounded if we have not identified it..
http://www.fda.gov/cder/fdama/difconc.htm (score=44)

GUIDE TO INSPECTIONS OF TOPICAL DRUG PRODUCTS
...Excessive temperatures may cause physical and/or chemical degradation of the drug product.....Particle size can also affect the activity of the drug substance because the smaller the.....Particle size also affects the degree to which the product may be physically irritating..
http://www.fda.gov/ora/inspect_ref/igs/topic.html (score=38)

OTC Labeling:  Questions and Answers
...Since most OTC drug product labeling is routinely updated and reprinted every few years, the.....5-point minimum type size is not readable, and another study presented information that 6.....Homeopathic drug products are subject to the same labeling provisions of the Food, Drug, and Cosmetic Act as other drug..
http://www.fda.gov/cder/otc/label/quesanswers.htm (score=37)

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...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.....responsible for ensuring that the rest of the product labeling complies with 21 CFR 201.66..
http://www.fda.gov/cder/guidance/3437dft.pdf (score=36)

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 development of a product and its manufacturing process and specifications, the design.....The size and even the type of granule can affect the pore size in a tablet and have an..
http://www.fda.gov/ora/inspect_ref/igs/solid.html (score=33)

...Should we conduct studies where the new drug product X is superior to letrozole or drug X is.....Sridhara will review for you shortly, the sample size needed for a non-inferiority study.....Also, we need to keep in mind when we look at these endpoints that there are drug-drug..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3782t1_01.htm (score=32)

Product Name Placement, Size, and Prominence in Advertising an
...This guidance is intended to clarify for applicants the requirements for product name placement,size, and.....with the proprietary name for drug products, and the proper name for a biological product.....This guidance represents the Agency's current thinking on product name placement,size, and prominence in..
http://www.fda.gov/cder/guidance/1955dft.pdf (score=30)

The New Food Label
...If the product doesn't, and the differences materially limit the product's use, its 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..
http://www.fda.gov/opacom/backgrounders/foodlabel/newlabel.html (score=30)

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