FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...Even slight changes in the formulation, drug substance particle size, valve, or actuator can have a major.....In addition, careful control of the impurities and degradation products in the drug substance and drug formulation.....In addition, careful control of the impurities and degradation products in the drug substance and other drug formulation..
http://www.fda.gov/cder/fdama/difconc.htm (score=100)

MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....an internal reservoir containing sufficient formulation for multiple doses that are.....of each facility involved in the manufacturing of the drug substance and excipients should..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=36)

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 other ingredients, with.....A discussion of any differences in formulation, manufacturing process, or site between the.....trials materials and commercial production batches of drug substance and drug product should be..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=35)

...DRUG SUBSTANCE The drug substance is defined as the unformulated active substance which may be subsequently.....If an investigational drug formulation was different from that of the to-be-marketed finished.....Raw Materials and Reagents A list of all components used in the manufacture of the drug..
http://www.fda.gov/cber/gdlns/cmcdna.txt (score=31)

Guidance for Industry Botanical Drug Products
...These regulations require documentation of the drug substance, drug product, placebo, labeling.....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..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=25)

/a/content.11865
...For the patent referenced above, provide the following information on the drug substance, drug.....Drug Product (Composition/Formulation) 3.1 Does the patent claim the drug product, as defined in 21 CFR 314.3, in.....1 Does the patent claim the drug substance that is the active ingredient in the drug..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3542a.pdf (score=24)

Guideline for Submitting Supporting Documentation
...Contract laboratories performing quality control tests on raw materials, drug substance, or the.....An amendment should be filed for any significant changes in formulation not proposed in.....An assay method including adequate acceptance specifications for content of the new drug..
http://www.fda.gov/cder/guidance/drugprod.htm (score=23)

...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.....Drug Substance (Active Ingredient) Complete all items in this section if the patent claims the..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3542a.doc (score=23)

Format and Content for the CMC Section of an Annual Report
...Regulatory specifications and analytical methods for the drug substance and drug..product.....To describe the information requested by the Center for Drug Evaluation and Research(CDER.....Methods for the drug substance and drug product in the format provided. III. SPECIFICATIONS AND..
http://www.fda.gov/cder/guidance/cmc1.pdf (score=22)

Guidance for Industry
...A complicating,but necessary design feature of MDIs is that they contain more formulation.....This guidance is intended to assist manufacturers who are developing or plan to develop.....This additional amount of formulation (propellant,drug substance, and any excipients) is necessary to ensure the dosing..
http://www.fda.gov/cder/guidance/5308FNL.pdf (score=45)

...So, it's both involved in formulation development to find out a proper formulation for that drug substance, as well.....So, that critical step is the drug substance coming out of the formulation, and as you'll see, I have a schematic of that.....Well, this is another study with the same active drug substance, drug B, and there are two..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3764t1.txt (score=35)

Microsoft Word - 3640fnl.doc
...ultraviolet/visible radiation absorption spectrum for the drug substance or drug..formulation, as appropriate, is.....absorption of the drug substance for one formulation do not necessarily supply relevant..data on the absorption.....the proposed mechanisms by which drug substances or drug products can enhance UV-associated skin..
http://www.fda.gov/cder/guidance/3640fnl.pdf (score=35)

...So, it's both involved in formulation development to find out a proper formulation for that drug substance, as well.....So, that critical step is the drug substance coming out of the formulation, and as you'll see, I have a schematic of that.....Well, this is another study with the same active drug substance, drug B, and there are two..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3764t1.htm (score=35)

...Information regarding the ultraviolet/visible radiation absorption spectrum for the drug substance or drug.....Studies of dermal absorption of the drug substance for one formulation do not necessarily supply relevant data on.....General Considerations for Testing a Drug Product or Drug Substance For most drugs, it is generally adequate to..
http://www.fda.gov/cder/guidance/3640fnl.doc (score=34)

News Along the Pike July 2004 Issue
...He also discussed ophthalmic drug formulation, dosing frequency, dosing volume and study.....from CDER’s Controlled Substance Staff, discussed how drugs are assessed for abuse.....Review divisions can consult with the Controlled Substance Staff at any time during the..
http://www.fda.gov/cder/pike/July2004.htm (score=33)

FOOD AND DRUG ADMINISTRATION
...Well, we certainly want the particle sizing of the micronized drug substance characterized and.....Meyer indicated in his slide, there's a package of information with the formulation/device.....So, if a drug is better than placebo, and with all available tests that drug is safe, that drug is safe and..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3763t1.htm (score=32)

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...For most drugs, it is generally acceptable to test only the drug substance for phototoxicity.....previously studied for phototoxic effects in a new formulation could also warrant testing.....and their effects on the penetration of the drug substance into the skin is useful in..
http://www.fda.gov/cder/guidance/3281dft.pdf (score=32)

...Well, we certainly want the particle sizing of the micronized drug substance characterized and.....Meyer indicated in his slide, there's a package of information with the formulation/device.....So, if a drug is better than placebo, and with all available tests that drug is safe, that drug is safe and..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3763t1.txt (score=32)

Guidance for Industry: FOR THE SUBMISSION OF CHEMISTRY, MANUFACTURING, AND...
...drug formulation was different from that of the to-be-marketed finished product, data to.....If the drug substance is intended to be sterile, evidence of container and closure integrity.....A discussion of any differences in formulation,manufacturing process, or site between the..
http://www.fda.gov/cber/gdlns/cmcdna.pdf (score=31)

Guidance for Industry - Content and Format of Chemistry, Manufacturing and...
...This section of the guidance refers to drug substances derived from another drug substance or intermediate through chemical or.....If an investigational drug formulation was different from that of the to-be-marketed finished.....The quality and purity of the drug substance cannot be assured solely by downstream testing..
http://www.fda.gov/cber/gdlns/cmcvacc.htm (score=31)

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