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=100)

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=69)

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=69)

stability guidance -draft
...Historically, all changes in drug product formulation were grouped together and required.....this guidance to mean a batch of drug substance or drug product manufactured at the scale typically encountered.....the same formulation of the dosage form in the container and closure proposed for..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=58)

Guidance for Industry: Q3C Impurities: Residual Solvents
...The manufacturer could test the drug product to determine if the formulation process reduced.....The maximum administered daily mass of a drug product is 5.0 g, and the drug product contains.....If all excipients and drug substances in a formulation meet the limits given in Option 1, then these components..
http://www.fda.gov/cber/gdlns/q3cresolvent.htm (score=56)

Guidance for Industry: Q3C Impurities: Residual Solvents
...cumulative method may be used to calculate the residual solvent levels in the drug product from.....solvents to be used in the synthesis and formulation of pharmaceutical products should be.....equal to or below that recommended in this guidance, no testing of the drug product for..
http://www.fda.gov/cber/gdlns/q3cresolvent.pdf (score=56)

...20 Ingress or leaching of such chemicals into 21 drug product formulation poses a safety concern for 22.....This increases the likelihood for 6 administration of the wrong drug product by the 7 wrong.....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=55)

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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=52)

/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=52)

Drug Product ListingForm FDA 2657
...This is the number assigned by the FDA to each site where the drug product listed is.....A bulk drug substance is any substance represented for use in a drug and when in the.....Print or type all data in English except the product trade name which may be entered as..
http://www.fda.gov/cder/drls/form2657.htm (score=52)

...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=50)

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=45)

Q1B Photostability Testing of New Drug Substances and Products
...The extent of drug product testing should be established by assessing whether or not acceptable.....These studies are used to identify precautionary measures needed in manufacturing or.....Testing should progress until the results demonstrate that the drug product is adequately..
http://www.fda.gov/cder/guidance/1318.htm (score=44)

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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=42)

About the Inactive Ingredients Database
...Does the Inactive Ingredients Database include contaminants found in approved drug.....Active ingredients include those components of the product that may undergo chemical.....product formulation. Reactants in radiopharmaceutical kits, or inactive ingredients that..
http://www.fda.gov/cder/iig/iigfaqWEB.htm (score=39)

...The drug product's formulation provides consistent pharmacokinetic performance between individual dosage.....Systemic exposure patterns reflect both release of the drug substance from the drug product and a series of possible.....In each comparison, the new formulation or new method of manufacture is the test product and the prior..
http://www.fda.gov/cder/guidance/5356fnl.doc (score=39)

...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=39)

...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=39)

Statement of Daniel E. Troy, Chief Counsel, U.S. Food and Drug...
...The submission of an ANDA for a drug product claimed in a patent is an infringing act if the.....When an NDA applicant submits a patent covering the formulation, composition, or method of.....This 30-month stay will delay approval of the generic drug product unless the court reaches a..
http://www.fda.gov/ola/2003/generic0617.html (score=38)

Federal Register: August 14, 1997 (Volume 62, Number 157
...A citizen petition claiming that a particular drug product is not subject to the new drug.....Another study estimated that the levothyroxine content of the old formulation was.....A citizen petition that contends that a particular drug product is not subject to the new drug..
http://www.fda.gov/cder/fedreg/fr14au97-83.htm (score=36)

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