Document
...Induced cardiac arrhythmias, many other cases, the biological product same meaning as.....ADVERSE DRUG EXPERIENCE REPORTS AND THE PROPOSED CONTENT OF TPSRS. Proposed revisions to content of periodic adverse drug.....the early months after product launch to Improving the quality and timeliness of warning..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5204.pdf (score=100)

Guidance for Industry Pre-Storage Leukocyte Reduction of Whole Blood and...
...to be monitored under controlled conditions that assure product purity, consistency,and.....the leukocyte content in accordance with established product specifications. The equipment.....leukocyte content of less than 1.0 x 106 per unit, data to support the recognition of..
http://www.fda.gov/cber/gdlns/preleuk.pdf (score=97)

...Implementation of Proposed Content and Format Revisions to Products Approved or Submitted.....These changes would simplify drug product labels and reduce the possibility of medication.....The regulations governing the format and content of labeling for prescription drugs and..
http://www.fda.gov/OHRMS/DOCKETS/98fr/122200a.htm (score=34)

MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....distribution, crystallinity, dose content uniformity, microbial content, and stability.....program because they can affect the ability of the product to deliver reproducible doses..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=33)

FR Doc 03-17525
...Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of.....Thus, the presence or absence of trans fat in a food product is a material fact under.....Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims AGENCY..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-17525.htm (score=33)

Guidance for Industry: Industry-Supported Scientific and Educational Activities
...that the company and provider agree to, the ultimate content of presentations is.....competing product, or suggest a use for.. example, be shown by labeling claims, factors.....Company Funding on the Content of Continuing.. Symposiums in Medical Journals,''New..
http://www.fda.gov/cber/gdlns/sciedu.pdf (score=32)

The New Food Label: A Little 'Lite' Reading
...Manufacturers who want to compare a nutritionally altered product with the regular product may make a relative.....The regulations spell out which nutrient content claims are allowed and under what.....Second, that the sodium content of a low-calorie, low-fat food has been reduced by 50..
http://www.fda.gov/fdac/special/foodlabel/lite.html (score=31)

The New Food Label
...If the product doesn't, and the differences materially limit the product's use, its label.....FDA requires nutrition information for foods about which health or nutrient-content claims.....Also, these foods will lose their exemption if their labels carry a nutrient content or..
http://www.fda.gov/opacom/backgrounders/foodlabel/newlabel.html (score=31)

The New Food Label
...If the product doesn't, and the differences materially limit the product's use, its label.....FDA requires nutrition information for foods about which health or nutrient-content claims.....Also, these foods will lose their exemption if their labels carry a nutrient content or..
http://www.fda.gov/opacom/backgrounders/foodlabel/newlabel.html?femalemuscle.com (score=31)

Guidance- Content & Format CMC for Vaccine & Related Product
...If the drug product is frozen, data supporting the stability of the product through a.....This guidance document represents FDA's current thinking on the content and format of the.....establishment and use of reference standards in assuring consistency in product..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=31)

IND content and format for Phase 1 studies
...As clinical development of a drug product proceeds,sponsors should discuss the.....and the general requirements for an IND's content and format. III. CLARIFICATIONS OF.....manufacture of the investigational drug product,including both those components intended..
http://www.fda.gov/cder/guidance/phase1.pdf (score=31)

Natural Ovens of Manitowoc, Inc. Warning Letter
...We reviewed product labels and analyzed samples of your 7 Grain Herb Bread, Multi-Grain.....FDA analyzed a sample of this bread for nutrient content and Omega-3 fatty acid content. This analysis reveals your.....FDA analyzed a sample of this bread for nutrient content and Omega-3 fatty acid content. This analysis reveals your..
http://www.fda.gov/foi/warning_letters/g3941d.htm (score=31)

...Conduct testing for uniform content of the finished product using an appropriate procedure or as specified in the.....The subsections below describe how to assess the adequacy of powder mix, uniformity of.....The FDA does not intend to inspect research data collected on an existing product for the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0493-gdl0001.doc (score=31)

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