Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical...
...drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise.....This result highlights the importance of assessing physical stability during drug.....Kruskal described many other possibilities for combined drug/device or biologic/device..
http://www.fda.gov/oc/combination/workshop070803.html (score=100)

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...Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug.....Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (I.....Help-Seeking" and Other Disease Awareness Communications by or on Behalf of Drug and..
http://www.fda.gov/cder/guidance/guidlist.pdf (score=57)

HUMAN DRUG CGMP NOTES September 1996
...Failing to submit annual reports or excluding specific lots from the stability program in.....What types of failures must a batch of new drug product exhibit to trigger a field alert.....drug/device product approval list, drug quality reporting system forms, a data standards manual..
http://www.fda.gov/cder/hdn/hdn996.htm (score=44)

March/April 1997 FDA Veterinarian Newsletter
...Veterinarians rarely have the ability to establish drug stability, physical and chemical.....Section 801(e)(1) states, "A food, drug, device, or cosmetic intended for export shall not be.....Chemists cannot predict, with great confidence, the stability of formulated products..
http://www.fda.gov/cvm/index/fdavet/1997/march.htm (score=42)

ICH; Guidance for Industry Q1D Bracketing and Matrixing Designs for...
...When a secondary packaging system contributes to the stability of the drug product, matrixing can be.....drug-device interactions. For the study of drug substances, matrixing is of limited utility and.....Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and..
http://www.fda.gov/cber/gdlns/ichq1d.htm (score=41)

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...When a secondary packaging system contributes to the stability of the drug product.....where there are a large number of potential drug-device interactions. For the study of.....that the stability of any intermediate levels is represented by the stability of the..
http://www.fda.gov/cber/gdlns/ichq1d.pdf (score=40)

/a/content.25505
...inactive drug ingredient sin FDA-approved drug prod- Exception from Informed Consent.....Products for the Treatment of Systemic Candida infec- Device GMPs to Computerized Devices.....Matrixing Designs for Stability Testing of New Drug.. Actives Post-approval Changes..
http://www.fda.gov/ora/inspect_ref/iom/pdf/Chapter10.pdf (score=40)

MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....manufacturing, processing, packaging, controls, stability testing, or labeling operations.....DPIs, the formulation, and the device with all of its parts including any protective..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=33)

...Any investigational drug, device, or biological product packaged separately that according to.....Under the QS regulation, for a combination product with a drug constituent part, yield and stability requirements would be.....Background Section 501 of the Act states the circumstances under which a drug or device is deemed..
http://www.fda.gov/cder/guidance/OCLove1dft.doc (score=131)

Current Good Manufacturing Practice for Combination Products
...Any investigational drug, device, or biological product packaged separately that according to.....Under the QS regulation, for a combination product with a drug constituent part, yield and stability requirements would be.....Section 501 of the Act states the circumstances under which a drug or device is deemed adulterated..
http://www.fda.gov/cder/guidance/OCLove1dft.htm (score=116)

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...Abbreviated New Drug Applications and 505(b)(2) Applications under Hatch-Waxman as Amended.....Submitting a New Drug Application .. The Use of Clinical Holds Following Clinical.....Drug/Device/Biologic) Computerized Systems Used in Clinical Trials .. Clinical Medical .. Level..
http://www.fda.gov/cder/guidance/new%20revised%20withdrawn%20-%20200412.pdf (score=86)

IND Meetings for Human Drugs and Biologics
...2 The terms investigational new drug or drug as used in this guidance refer to the drug and/or.....Assurance that the submission will contain adequate stability data in accordance with stability protocols agreed upon at the.....demonstration of device and its characteristics, potential for overly rapid release of..
http://www.fda.gov/cder/guidance/3683fnl.htm (score=55)

Guidance for Industry - IND Meetings for Human Drugs and Biologics...
...Assurance that the submission will contain adequate stability data in accordance with stability protocols agreed upon at the.....The meetings, which often coincide with critical points in the drug development and/or.....demonstration of device and its characteristics, potential for overly rapid release of..
http://www.fda.gov/cber/gdlns/ind052501.htm (score=55)

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...sponsor, drug, route of synthesis or isolation, dosage form, formulation, stability, route.....demonstration of device and its characteristics, potential for overly rapid release of.....2 The terms investigational new drug or drug as used in this guidance refer to the drug and/or..
http://www.fda.gov/cder/guidance/3683fnl.pdf (score=55)

Deciding When to Submit a 510(k)
...Moreover, the guidance is not intended to apply to combination products, such as drug/device or.....used to establish a property or the stability of the material. This does not include.....Wherever possible, existing definitions from the Food, Drug, and Cosmetic Act, the medical device regulations, or ODE Bluebook..
http://www.fda.gov/cdrh/ode/510kmod.html (score=54)

510KMOD.PDF
...Wherever possible, existing definitions from the Food, Drug, and Cosmetic Act,the medical device regulations, or ODE Bluebook.....affect the chemistry, metallurgy, or other property or stability of the material. These do.....Almost from the enactment of the Medical Device Amendments to the Federal Food,Drug, and Cosmetic Act in 1976, FDA staff have..
http://www.fda.gov/cdrh/ode/510kmod.pdf (score=39)

News Along the Pike, August 2002
...Among other 1962 events was passage of the Kefauver-Harris amendments to the Food, Drug and Cosmetic Act requiring drug.....OTR completed the initial lab work to determine the stability and dosing uniformity of.....drug-device combinations and an entire afternoon session devoted to pediatric issues during pre..
http://www.fda.gov/cder/pike/august2002.htm (score=39)

...Nucleic Acid Characterization and Genetic Stability Draft PTC in the Characterization of.....Drug Advertising and Promotional Labeling DDMAC 2 Dissemination of Reprints of Certain.....Questions and Answers January 1, 1985 Do Do from FDA, from Medical Device and Diagnostic..
http://www.fda.gov/cber/gdlns/guidelst.txt (score=28)

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