Therapeutic Equivalence of Generic Drugs Letter
...For example, brand-name and generic drug product manufacturers may want to change the drug.....FDA works with both brand-name and generic drug product manufacturers after a drug product is in the marketplace to assure its.....Special precautions are not needed when a formulation and/or a manufacturing change occurs..
http://www.fda.gov/cder/news/nightgenlett.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=74)

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=60)

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=59)

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=58)

...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=58)

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=58)

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=55)

/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=55)

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=54)

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=52)

...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=51)

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=51)

Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical...
...The presence of membrane disrupters, often used in drug formulation, is also a big problem for.....An example given was the development of Gliadel, a controlled release drug product for the.....First, to what extent does the modification of the drug formulation to optimize delivery with..
http://www.fda.gov/oc/combination/workshop070803.html (score=127)

March/April 1997 FDA Veterinarian Newsletter
...The determination of whether a product will be approved as a VFD drug or as an over-the.....Equine practitioners often must treat animals where no approved formulation exists, or.....The highest assurance for safe and effective use of a drug comes when the available drug..
http://www.fda.gov/cvm/index/fdavet/1997/march.htm (score=105)

Microsoft Word - 3640fnl.doc
...For topical products that will be applied to sun-exposed skin, FDA recommends that the drug.....ultraviolet/visible radiation absorption spectrum for the drug substance or drug..formulation, as appropriate, is.....nonphotoreactive drug product increased transmission of UV radiation through the skin,resulting..
http://www.fda.gov/cder/guidance/3640fnl.pdf (score=77)

...Information regarding the ultraviolet/visible radiation absorption spectrum for the drug substance or drug.....A photoactive chemical can be the parent drug or an excipient in a drug product, or it can be a metabolite, impurity, or.....General Considerations for Testing a Drug Product or Drug Substance For most drugs, it is..
http://www.fda.gov/cder/guidance/3640fnl.doc (score=76)

Guidance- Content & Format CMC for Vaccine & Related Product
...A list should be provided of all components in the drug product, including drug substance(s)and.....A discussion of any differences in formulation, manufacturing process, or site between the.....This section should contain information on the final drug product including all drug substances..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=75)

News Along the Pike July 2004 Issue
...He also discussed ophthalmic drug formulation, dosing frequency, dosing volume and study.....The Microbiology Section includes review of drug product solution filtration, specifications.....As with the previous version, the new version reaffirms that Agency drug product pre-market..
http://www.fda.gov/cder/pike/July2004.htm (score=75)

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...However, for topical products that will be applied to sun-exposed skin, the drug product, not.....previously studied for phototoxic effects in a new formulation could also warrant testing.....markers in the skin of humans receiving the drug product may clarify mechanisms of direct..
http://www.fda.gov/cder/guidance/3281dft.pdf (score=73)

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