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=100)

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=91)

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=30)

/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=29)

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=28)

...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=27)

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=27)

Statement of Daniel E. Troy, Chief Counsel, U.S. Food and Drug...
...Innovations in drug therapy are leading to new methods of drug delivery, including via liposomes, implantable systems, transcutaneous.....When an NDA applicant submits a patent covering the formulation, composition, or method of.....Patents that may be submitted are drug substance (active ingredient) patents, drug product..
http://www.fda.gov/ola/2003/generic0617.html (score=82)

Greater Access to Affordable Pharmaceuticals Act
...Innovations in drug therapy are leading to new methods of drug delivery, including via liposomes, implantable systems, transcutaneous.....When an NDA applicant submits a patent covering the formulation, composition, or method of.....Patents that may be submitted are drug substance (active ingredient) patents, drug product..
http://www.fda.gov/ola/2003/genericdrugs0801.html (score=81)

FDA Numerical Forms List
...Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation.....Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use.. Pamela.....Notification for a Food Contact Substance Formulation .. Mitchell Cheeseman ..202-418-3083..
http://www.fda.gov/opacom/morechoices/fdaforms/default.html (score=81)

GUIDE TO INSPECTIONS OF STERILE DRUG SUBSTANCE MANUFACTURERS
...This is particularly important for the foreign sterile bulk drug substance manufacturer where.....drug used in the formulation of sterile ophthalmic ointments and suspensions. If used as a primary.....In the preparation for a sterile bulk drug substance inspection, a flow chart with the major..
http://www.fda.gov/ora/inspect_ref/igs/subst.html (score=33)

stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale.....the same formulation of the dosage form in the container and closure proposed for.....process of a drug substance or drug product is made, sufficient data to show that such a change..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=31)

...These regulations require documentation of the drug substance, drug product, placebo, labeling.....In the case of a multi-herb substance, it is composed of the same formulation as a historical formula, with the amount of each.....A botanical drug substance or drug product that is derived from more than one botanical raw material, each..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=30)

Prel. draft List of drugs for Pharmacy Comp
...substance's acute toxicity and other reported toxicities, including mutagenicity.....of bulk drug substances that may be used in pharmacy compounding, it does not specify a.....formulation, FDA is proposing to include it on the bulk drugs.. list for use in this..
http://www.fda.gov/cder/fdama/draft4.pdf (score=30)

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=29)

...In fact, any person who represents that a compounded drug made with a bulk drug substance that appears on this list.....formulation, FDA is proposing to include it on the bulk drugs list for use in this dosage.....When evaluating a bulk drug substance used to treat a less serious illness, FDA will generally..
http://www.fda.gov/ohrms/dockets/98fr/010799b.txt (score=29)

WAIS Document Retrieval
...In fact, any person who represents that a compounded drug made with a bulk drug substance that appears on this list.....formulation, FDA is proposing to include it on the bulk drugs list for use in this dosage.....When evaluating a bulk drug substance used to treat a less serious illness, FDA will generally..
http://www.fda.gov/cder/fdama/pclist.txt (score=29)

Document
...351, 352, 353a, 355, nominated drug substances is limited, number and size of the bulk.....The Development of Operational, substance; the safety of the substance; approval is set.....through the new drug approval process, Academy of Compounding Pharmacists, rigorous and..
http://www.fda.gov/cder/fdama/pclist.pdf (score=29)

...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=28)

/a/content.30891
...all the clinical data on the to-be-marketed formulation, 6.. even if it is more than one.....rate and extent of drug absorption, its pharmacokinetics, 16.. pharmacodynamics, and the.....release of the drug substance from the drug product and its.. 13.. absorption into the systemic..
http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3657t2.pdf (score=28)

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