ENFORCEMENT REPORT FOR MARCH 24, 2000
...REASON Subpotency (at 12 month stability). RECALLS AND FIELD CORRECTIONS: BIOLOGICS.....REASON One degradant exceeded specification during stability testing. ________ PRODUCT.....REASON Subpotent iron content (stability testing) and crystalline precipitate..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00643.html (score=100)

MDI and DPI Drug Products
...manufacturing, processing, packaging, controls, stability testing, or labeling operations.....distribution, crystallinity, dose content uniformity, microbial content, and stability.....emitted dose content uniformity, particle size distribution, microscopic evaluation, 1619..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=36)

Guidance- Content & Format CMC for Vaccine & Related Product
...This section should contain information on the stability of the drug substance and any in.....This guidance document represents FDA's current thinking on the content and format of the.....material at each holding step, as outlined in "Stability Testing of New Drug Substances..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=34)

IND content and format for Phase 1 studies
...A brief description of the stability study and the test..methods used to monitor the.....and the general requirements for an IND's content and format. III. CLARIFICATIONS OF.....A brief description of the stability study and the test..methods used to monitor the..
http://www.fda.gov/cder/guidance/phase1.pdf (score=32)

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...Format and Content of the Human Pharmacokinetics and Bioavailability Section of an.....Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (I.....Content and Format of INDs for Phase 1 Studies of Drugs Including Well-Characterized, 10/4..
http://www.fda.gov/cder/guidance/guidlist.pdf (score=31)

...Nucleic Acid Characterization and Genetic Stability Draft PTC in the Characterization of.....the decision making tree Suggested Content for Original IDE February 27, 1996 Do Do.....0 Guidance for the Preparation and December 4, 1987 Do Do Content of Applications to the..
http://www.fda.gov/cber/gdlns/guidelst.txt (score=30)

Selected Guidance Documents Applicable to Combination Products
...Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial.....Submitting Documentation for the Stability of Human Drugs and Biologics.. Submitting.....Content and Format of the Adverse Reactions Section of Labeling for Human Prescription..
http://www.fda.gov/oc/combination/guidance.html (score=30)

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