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...available about cosmetic product formulations, ingredients and their frequency of use.....The data in original cosmetic product formulation statements and notices of.. discontinance are.....The data in amended cosmetic product formulation statements are.. submitted only if a manufacturer..
http://www.fda.gov/OHRMS/DOCKETS/98fr/020268ss.PDF (score=100)

Product Approval - Antihemophilic Factor (Recombinant), Kogenate FS, Bayer...
...Product Approval - Antihemophilic Factor (Recombinant), Kogenate FS, Bayer Corp.....New product formulation.. Approval Date: 6/26/2000.. Type of submission: Biologics license.....Product Approval Information - Licensing Action.. Proper name: Antihemophilic Factor..
http://www.fda.gov/cber/products/ahfbay062600.htm (score=59)

FDA's New Regulation to Speed Access to Lower Cost Generic Drugs About...
...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..
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00932.html (score=59)

MDI and DPI Drug Products
...an internal reservoir containing sufficient formulation for multiple doses that are.....The guidance sets forth information that should be provided to ensure continuing drug.....formulation, moisture level, consistency of filling operation, particle size distribution..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=49)

WAIS Document Retrieval
...The comment argued that determination of eye irritancy should be based on total product.....The potential for titanium dioxide particles to agglomerate in formulation, which could.....The agency advises that on or after May 21, 2001, no OTC drug product that is subject to..
http://www.fda.gov/cder/fdama/fedreg/sunscreen.txt (score=47)

...20 Ingress or leaching of such chemicals into 21 drug product formulation poses a safety concern.....12 So, in a nutshell, product contamination 13 can occur because of the formulation.....There are many more 19 proprietary chemicals used in the formulation of 20 these adhesives..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4040T1.DOC (score=46)

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...formulation components or leaching from the container closure system, chemical impurities.....environment, particularly the secondary packaging, can react with the drug product to form.....bronchospasm after the use of a drug product is due to chemical contaminants or to the..
http://www.fda.gov/cder/guidance/4168dft.pdf (score=46)

Liquid Chemical Sterilants
...Provide a brief toxicity profile of the final product formulation of the germicide and/or the.....Describe the microbial mode of action of the final product formulation of the germicide.....a change in the chemical composition of the germicide formulation, such as addition of a..
http://www.fda.gov/cdrh/ode/lcgguide.html (score=46)

...One article claimed that ZGP’s product does not work the same nor as well as the brand.....product formulation had been changed. This lack of knowledge may have contributed to the.....If FDA finds evidence demonstrating a problem with this or any drug product, it will take..
http://www.fda.gov/cder/drug/infopage/clozapine/clozapine.htm (score=46)

/a/content.11865
...1 Does the patent claim the drug substance that is the active ingredient in the drug.....Drug Product (Composition/Formulation) 3.1 Does the patent claim the drug product, as defined in 21 CFR 314.3.....53(d) to change the formulation, add a new.. method of using the approved drug product to..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3542a.pdf (score=46)

...If the patent claims an approved method of using the approved drug product to administer.....53(d) to change the formulation, add a new indication or other condition of use, change.....3) An answer to this question is required only if the referenced patent is a product-by..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3542a.doc (score=46)

CBER Regulatory SOPP 8401.5 Processing of Animal Component Information...
...The CMC/Product reviewer will review the submission to determine if components of animal.....product formulation. CBER reviews these products through a variety of submissions, including.....formulation or are otherwise used in production and/or contact with the product. The CMC..
http://www.fda.gov/cber/regsopp/84015.htm (score=46)

Interstate Bakeries Issues Voluntary Recall of Mislabeled Great Value Bread...
...During a routine review of product formulation, it was discovered that the whey used in these.....FDA does not endorse either the product or the company. Interstate Bakeries Issues.....product. Packages of the recalled bread are marked with the SELL BY DATES of September..
http://www.fda.gov/oc/po/firmrecalls/interstate10_04.html (score=45)

/a/content.21324
...If more than one cosmetic product has been filed under the Cosmetic Product Ingredient.....OF COSMETIC PRODUCT FORMULATION .. (In accordance with 21 CFR 720) Public reporting burden for.....COMMENTS (if any) *Submission of Form FDA 2514 will discontinue an entire Cosmetic Product..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-2514.pdf (score=45)

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...formulation components or leaching from the container closure system, chemical impurities.....environment, particularly the secondary packaging, can react with the drug product to form.....bronchospasm after the use of a drug product is due to chemical contaminants or to the..
http://www.fda.gov/cder/guidance/4168dft.PDF (score=32)

STATEMENT BY GARY BUEHLER, RPh, May 24, 2001
...When an NDA applicant submits a patent covering the formulation, composition, or method of.....Innovator drug applicants must include in an NDA information about patents for the drug.....The submission of an ANDA for a drug product claimed in a patent is an infringing act if..
http://www.fda.gov/ola/2001/generic0524.html (score=32)

FDA Forms Distribution Page for CFSAN
...Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation.....Notification for a Food Contact Substance Formulation .. Mitchell Cheeseman .. 202-418.....Registration of Cosmetic Product Establishment{Instructions} VCRP ..202-418-3414.. 2512..
http://www.fda.gov/opacom/morechoices/fdaforms/cfsan.html (score=32)

Gulf Coast Crab International Co., Ltd. Warning Letter
...You must take affirmative steps to ensure that the fishery product you import, namely.....The study does not identify the number of product containers in each batch tested, the.....product formulation. Under 21 CFR 123.12(a)(2)(ii)(D), if you take affirmative steps by..
http://www.fda.gov/foi/warning_letters/g3912d.htm (score=32)

About the Inactive Ingredients Database
...Active ingredients include those components of the product that may undergo chemical.....product formulation. Reactants in radiopharmaceutical kits, or inactive ingredients that.....product and be present in the drug product in a modified form intended to furnish the..
http://www.fda.gov/cder/iig/iigfaqWEB.htm (score=32)

lacfpt201.html
...Product Formulation.. Pg. 6.. Packing Medium.. Pg. 7.. Filling of Containers-Critical..
http://www.fda.gov/ora/inspect_ref/igs/lacfpt2/lacfpt201.html (score=32)

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