MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....An alternative approach may be used if such approach satisfies the requirements of the.....also known as oral and nasal metered dose inhalers respectively or MDIs) and inhalation..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....used if such approach satisfies the requirements of the applicable statutes and.....or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=97)

PTC in Manufacture and Testing of Monoclonal Antibody Products for Human Use
...These trials cannot be used by themselves to support licensure of a product.Studies conducted in normal volunteers are not included in.....higher estimate of the absorbed dose determined from either of these systems should be.....entity or is produced by a novel process, and when drug development plans are unusually..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=94)

Guidance for Industry
...However, if a radioactive drug is used for immediate therapeutic, diagnostic, or similar purpose.....In studies that compare the effects of a test agent with another drug, biological product.....We recommend that sponsors explore the consequences of both mass dose and radiation dose..
http://www.fda.gov/cder/guidance/5742prt3.pdf (score=94)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Currently, a batch, or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug product in a.....Equipment used in the production, processing, or packaging of a PET drug product should be.....An alternative approach may be used if such approach satisfies the requirements of the..
http://www.fda.gov/cder/guidance/4259dft.htm (score=93)

Guidance for Industry: Human Somatic Cell Therapy and Gene Therapy
...abbreviate testing and IND submission for a product or product series, the sponsor should.....Virus or DNA preparations used as preventive vaccines are not covered by this document.....Murphy, HFM-17, Center for Biologics Evaluation and Research, Food and Drug Administration..
http://www.fda.gov/cber/gdlns/somgene.pdf (score=91)

...only a limited characterization of the processes used to prepare the product for their ability to remove.....Sponsors should study a number of separate product lots during drug development to demonstrate that a safe and.....The mathematical equations used to derive the estimates of the radiation dose and the absorbed dose should be..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=91)

Document
...number in this manner would, code requirement, and we consider drug doses of the drug.....drugs are used in hospitals, so bar codes errors involving radiopharmaceuticals, bar codes.....manufacturer, product, and package. prevent the introduction, transmission, drug product..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.pdf (score=90)

ICH: Guidance on Viral Safety Eveluation of Biotechnology Products Derived...
...and for the removal of virus from product, acceptable level of safety in the final product.....used in the context of the understanding of the biology of the virus and the nature of the.....Food and Drug Administration, AGENCY: Food and Drug Administration, Clearance Officer..
http://www.fda.gov/cber/gdlns/virsafe.pdf (score=83)

...To ensure that a botanical drug product used in clinical trials is of consistently good quality, and.....Because the product is marketed and the dose that is thought to be appropriate and well tolerated is known, there.....A chemical constituent of a botanical raw material, drug substance, or drug product that is used for identification and/or quality..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=79)

stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale typically encountered.....demonstrate that the closure used with a multiple-dose vial is capable of withstanding the.....Ordinarily, the approved expiration dating period for the drug product may be retained if the..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=76)

Guidance for Industry: Developing Medical Imaging Drug and Biological...
...demonstrating whether the proposed drug product is safe for use under the conditions prescribed.....However, if a radioactive drug is used for immediate therapeutic, diagnostic, or similar purposes.....administered at a mass dose that is at the low end of the dose-response curve, dose..
http://www.fda.gov/cber/gdlns/medimagesaf.pdf (score=71)

CDER 2001 Report to the Nation
...Our systematic, adequate to preserve the drug product's identity, strength, potency, internal.....monkey study that had been used to support our August 2000 approval of ..ciprofloxacin for.....effective human dose. The Sept. 11 terrorist attacks and the subsequent anthrax attacks..
http://www.fda.gov/cder/reports/rtn/2001/rtn2001.pdf (score=1)

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