Accutane Update
...label requires that the drug be prescribed only after female patients have had a negative..
http://www.fda.gov/bbs/topics/answers/ans00082.html (score=100)

Accutane Update
...label requires that the drug be prescribed only after female patients have had a negative..
http://www.fda.gov/bbs/topics/ANSWERS/ANS00082.html (score=100)

Ingredient Labeling: What's in a Food?
...FDA now requires that ingredients for all standardized foods be listed on the label, the.....Furthermore, it guides people away from even checking the label for milk-derived.....Department of Agriculture requires full ingredient labeling on all meat and poultry..
http://www.fda.gov/fdac/special/foodlabel/ingred.html (score=12)

New Food Label: Good Reading for Good Eating (May 1993)
...Among other things, it requires the label of every processed, packaged food to contain the name of the.....The new food label is reading that can be put to good use, too, because it's designed to.....1950 The Oleomargarine Act requires prominent labeling of colored oleomargarine to..
http://www.fda.gov/bbs/topics/CONSUMER/CON00216.html (score=13)

THE NEW OTC DRUG FACTS LABEL PROMOTING THE SAFE USE OF OTC MEDICINES
...Many manufacturers have voluntarily adapted the new OTC label even before the May 16th.....The OTC regulation FDA finalized in March 1999 requires a standardized format for the.....label. Although in many cases the new label began appearing on the shelves within the last..
http://www.fda.gov/bbs/topics/NEWS/2002/NEW00807.html (score=13)

FR Doc 04-4249
...We also stated that requiring manufacturers, repackers, relabelers, and private label.....The rule also requires the use of machine-readable information on blood and blood.....Repackers, relabelers, and private label distributors that are exempt from the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.htm (score=13)

Bar Code Label Requirements for Human Drug Products and Biological...
...We also stated that requiring manufacturers, repackers, relabelers, and private label.....The rule also requires the use of machine-readable information on blood and blood.....Repackers, relabelers, and private label distributors that are exempt from the..
http://www.fda.gov/cber/rules/barcodelabel.htm (score=13)

Food Labeling: Good Reading for Good Eating
...Among other things, it requires the label of every processed, packaged food to contain the name of the.....The new food label is reading that can be put to good use, too, because it's designed to.....1950 The Oleomargarine Act requires prominent labeling of colored oleomargarine to..
http://www.fda.gov/fdac/special/foodlabel/goodread.html (score=13)

Document
...manufacturers, repackers, relabelers, which do not manufacture, prepare, and private label.....prosecution, and violation may result in The rule also requires machine-readable re.....Act requires that regulations determined which we contracted to collect data, directs..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.pdf (score=12)

...Thus, if FDA has not reviewed or approved the foreign-language label, the product is.....This section also requires persons exporting drugs or devices under any provision of.....One comment suggested that the label, alone, should be sufficient and that FDA should not..
http://www.fda.gov/ohrms/dockets/98fr/121901a.htm (score=12)

Fresh Air '2000' A look at FDA's Medical Gas Requirements
...305 requires any person whose name appears on the label of a marketed prescription drug.....There must be written procedures to assure that the correct label is used on the drug.....Section 510 of the Act requires all drug manufacturers, including fillers of medical gases..
http://www.fda.gov/cder/dmpq/freshair.htm (score=12)

PROPOSED NEW LABEL STATEMENT FOR ASPIRIN
...PROPOSED NEW LABEL STATEMENT FOR ASPIRIN The Food and Drug Administration is seeking.....requires supervision by a physician. Some manufacturers have recently begun suggesting on.....label statement for aspirin products. The notice would advise consumers to consult a..
http://www.fda.gov/bbs/topics/ANSWERS/ANS00533.html (score=12)

Summary of the EPRC Provisions of the FFDCA
...label on each product subject to a standard of the manufacturer's statement that the.....requires indication prior to initiation of scan, timer control to terminate or shutter the.....requires 2 interlocks on each door with 1 resulting in physical disconnection of energy to..
http://www.fda.gov/cdrh/radhlth/summary.html (score=12)

The New Food Label: A Little 'Lite' Reading
...For example, the standard for sour cream requires that the food contain 18 percent fat and.....If the food still does not meet the definition for "low sodium," the label must include.....FDA requires a "meal" to weigh at least 10 ounces and have at least three different foods..
http://www.fda.gov/fdac/special/foodlabel/lite.html (score=12)

E & M Corporation Warning Letter
...According to the FDA investigator’s report, you promised to apply label stickers declaring.....4(b)(14) requires that your product label declare the common or usual name of each fat and.....5, and the presence of that ingredient is not declared on the product label. You must..
http://www.fda.gov/foi/warning_letters/g3732d.htm (score=12)

FDA Consumer Magazine Table of Contents (July/August 1994)
...In the past, diet-conscious consumers couldn't always count on the food label to give.....The law requires controlled human trials to prove effectiveness before FDA can approve a..
http://www.fda.gov/bbs/topics/CONSUMER/CON00286.html (score=12)

FDA's Rx for Better Medication Information
...To prevent mix-ups, patients ought to insist that the medicine's purpose be put on the.....Federal law requires labeling on OTC medicines to include adequate directions for proper.....An additional benefit from a container label's stating the intended use, Morse says, is..
http://www.fda.gov/fdac/features/995_medinfo.html (score=12)

AMDUCA FEDERAL REGISTER NOTICE
...The agency believes that the regulations clearly distinguish between the extra-label.....The statute requires that there be substantial evidence that an NAD is effective for its.....The Regulatory Flexibility Act requires agencies to analyze regulatory options that would..
http://www.fda.gov/cvm/index/amducca/amducafr.htm (score=12)

...With regard to the marketing of dietary supplements with a label statement that the.....DSHEA also requires the manufacturer of a dietary supplement bearing a statement under.....Instead, it requires that claims about disease uses meet certain standards of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/010600a.txt (score=12)

Good Manufacturing Practices (GMP) / Quality Systems (QS)
...This labeling regulation requires that where the person or manufacturer named on the label.....A distributor who only adds a label bearing their name and address is exempt from the GMP.....The regulation requires that various specifications and controls be established for..
http://www.fda.gov/cdrh/devadvice/32.html (score=12)

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