FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...A sophisticated formulation of the drug product is required to ensure dosing accuracy and reproducibility, and.....A sophisticated formulation of the drug product is required to ensure dosing accuracy and reproducibility, and the.....For these reasons, the drug formulation of a TDS product, including the interaction of all TDS components, is highly..
http://www.fda.gov/cder/fdama/difconc.htm (score=100)

MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....an internal reservoir containing sufficient formulation for multiple doses that are.....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=50)

WAIS Document Retrieval
...Any drug product labeled, represented, or promoted for use as an OTC sunscreen drug that.....The comment argued that determination of eye irritancy should be based on total product.....Such a claim to affect the structure or function of the body renders the product subject to regulation as a drug under..
http://www.fda.gov/cder/fdama/fedreg/sunscreen.txt (score=40)

FR Doc 03-14140
...Any drug product labeled, represented, or promoted for use as an OTC antiperspirant drug that.....Subjects applied the antiperspirant test formulation to one axilla and used either a.....A drug product that, when applied topically to the underarm, will reduce the production of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.htm (score=37)

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...system components are critical to ensure the quality and purity of the drug product and must be.....formulation components or leaching from the container closure system, chemical impurities.....environment, particularly the secondary packaging, can react with the drug product to form..
http://www.fda.gov/cder/guidance/4168dft.pdf (score=37)

Document
...as safe and effective and not misbranded active ingredients in OTC drug products document.....Even minor variations in formulation, effectiveness. formula is stated as: such as the.....product effectiveness. revising the guidelines to state: revising the relative humidity..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.pdf (score=37)

Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and...
...Where possible, an estimate of patient exposure to the drug product, with special reference to.....Under the Pediatric Rule you may be required to produce a pediatric formulation if one is.....The drug product does not represent a meaningful therapeutic benefit over existing treatments..
http://www.fda.gov/cder/guidance/3578dft.htm (score=36)

...Where possible, an estimate of patient exposure to the drug product, with special reference to.....Under the Pediatric Rule you may be required to produce a pediatric formulation if one is.....Pre-investigational new drug application meetings should include plans for studying the drug..
http://www.fda.gov/cder/guidance/3578dft.doc (score=36)

FDA's New Regulation to Speed Access to Lower Cost Generic Drugs About...
...The final rule also clarifies the types of drug patents that can be submitted for listing.....product developers are not subject to multiple regimes of regulation of generic drug.....drug substance (active ingredient), the drug product (formulation and composition), and the method of..
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00932.html (score=35)

/a/content.11865
...For the patent referenced above, provide the following information on the drug substance, drug product and/or.....Drug Product (Composition/Formulation) 3.1 Does the patent claim the drug product, as defined in 21 CFR 314.3, in.....data demonstrating that a drug product containing the polymorph will perform the same as the..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3542a.pdf (score=35)

...If FDA finds evidence demonstrating a problem with this or any drug product, it will take.....drug product formulation had been changed. This lack of knowledge may have contributed to the.....In addition, FDA will continue to monitor reports regarding ZGP’s drug product and has..
http://www.fda.gov/cder/drug/infopage/clozapine/clozapine.htm (score=35)

...If the patent claims an approved method of using the approved drug product to administer the.....53(d) to change the formulation, add a new indication or other condition of use, change.....Drug Product (Composition/Formulation) Complete all items in this section if the patent claims the drug product that..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3542a.doc (score=34)

Document
...to convene a panel of pediatric experts, existing drug advisory committees, FDA agrees.....methods that optimize safety, safety and effectiveness of the product, studies.....The AAP stated that premature infants, formulation had failed. compound is cleared from..
http://www.fda.gov/ohrms/dockets/98fr/120298c.pdf (score=34)

/a/content.30891
...slight changes in the formulation on product variability, 19.. because they may have made it the same way.....rate and extent of drug absorption, its pharmacokinetics, 16.. pharmacodynamics, and the.....all the clinical data on the to-be-marketed formulation, 6.. even if it is more than one..
http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3657t2.pdf (score=33)

Guideline for Submitting Supporting Documentation
...Approval of reprocessing procedures must be obtained before release of the reprocessed drug or drug.....An amendment should be filed for any significant changes in formulation not proposed in.....List all substances used in the manufacture of a drug product whether or not they appear in the..
http://www.fda.gov/cder/guidance/drugprod.htm (score=33)

January/February 1999 FDA Veterinarian Newsletter
...Since the cost of obtaining a drug approval for the product grossly outweighed any profit manufacturers could.....product. Demonstration that the product formulation consistently meets the cut-off.....The criteria for what constitutes a drug claim extend beyond the specific wording that a..
http://www.fda.gov/cvm/index/fdavet/1999/jan.html (score=32)

Guidance for Industry Botanical Drug Products
...These regulations require documentation of the drug substance, drug product, placebo, labeling, and an.....formulation and the individual botanical ingredients within the formulation must be.....one in which the components or ingredients and composition of the drug substance and drug product are kept..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=31)

Statement of Lester M. Crawford, D.V.M., Ph.D, October 9, 2002
...Innovator drug applicants must include, in an NDA, information about patents for the drug.....When an NDA applicant submits a patent covering the formulation, composition, or method of.....The submission of an ANDA for a drug product claimed in a patent is an infringing act if the..
http://www.fda.gov/ola/2002/hatch_waxman1009.html (score=31)

...Each product, each drug, each concentration may have its own unique profile, and that's why you do a.....The formulation of Avita is different from Retin-A, while the third tretinoin gel product.....And a critical event to be able to get therapeutic results from this product is the drug substance or..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3804t2.htm (score=31)

ICHE2A.
...the Executive Secretariat Staff, HFD-8, Center for Drug Evaluation and Research,7500.....an identifiable patient, the name of a suspect medicinal product,an identifiable reporting.....It is not uncommon that more than one dosage form, formulation,or delivery system (oral..
http://www.fda.gov/cder/guidance/iche2a.pdf (score=31)

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