MDI and DPI Drug Products
...An alternative approach may be used if such approach satisfies the requirements of the.....The guidance sets forth information that should be provided to ensure continuing drug.....and they are currently used by over 25 million Americans for a variety of diseases, such..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Guidance for Industry
...possible, the formulation that will be used for marketing should be used during phase 2.....In studies that compare the effects of a test agent with another drug, biological product.....An alternative approach may be used if such approach satisfies the requirements of the..
http://www.fda.gov/cder/guidance/5742prt3.pdf (score=99)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...used if such approach satisfies the requirements of the applicable statutes and.....ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....or give erroneous or invalid test results when improperly used or maintained, is clean, G..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=99)

GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS
...The BPC used to manufacture commercial batches must not significantly differ from that.....It would be unrealistic to expect drug product GMP concepts to apply to the production of.....This document is intended to aid agency personnel in determining whether the methods used..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=97)

CBER - Workshop on Development of Donor Screening Assays for West Nile Virus
...The riboflavin concentration with our RBC product is 500 micromolar, and the product volume was 266 ml at a hematocrit of 30.....This could be 1 in 100,000 units, we don't know, but until a method is used extensively.....This is another product of ours, the anti-inhibitor product FEIBA, which is subjected to vapor heat treatment process, and I..
http://www.fda.gov/cber/minutes/wnv110502.htm (score=95)

Guidance for Industry: Source Animal, Product, Preclinical and Clinical...
...from a nonhuman source, or xenotransplantation product materials used in encapsulated form.....Master Files are submitted to FDA and contain information regarding a product, such as product manufacture.....alternative approach may be used if such approach satisfies the requirements of the..
http://www.fda.gov/cber/gdlns/clinxeno.pdf (score=93)

Document
...drugs are used in hospitals, so bar codes errors involving radiopharmaceuticals, bar codes.....manufacturer, product, and package. prevent the introduction, transmission, drug product.....Contract printers are commonly used for with bar codes for specified concerns, contracted..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.pdf (score=93)

þÿ
...associated acceptance criteria depend on the route of administration of the drug product and the controls used.....substances is used to produce the drug product, the specifications for the individual drug.....its specification and, therefore, can be used in the manufacture of a given drug product..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=93)

...Generally, harvest material in which adventitious virus has been detected should not be used to manufacture the.....Acceptability of Cell Lines It is recognized that some cell lines used for the manufacture of product will contain.....An alternative approach may be used if such approach satisfies the requirements of the..
http://www.fda.gov/cber/gdlns/virsafe.txt (score=93)

þÿ
...associated acceptance criteria depend on the route of administration of the drug product and the controls used.....substances is used to produce the drug product, the specifications for the individual drug.....its specification and, therefore, can be used in the manufacture of a given drug product..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=89)

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.....EXAMPLES OF THE USE AND LIMITATIONS OF ASSAYS WHICH MAY BE USED TO TEST FOR VIRUS..
http://www.fda.gov/cber/gdlns/virsafe.pdf (score=87)

Blood Product Inspections
...If these are shipped interstate, the license number must not be on the product label and the product is not to.....it is a technical reference and is intended to be used in conjunction with the Inspection.....If equipment is used in the establishment that is not listed in the CFR, performance..
http://www.fda.gov/ora/inspect_ref/igs/blood.html (score=85)

General Principles of Software Validation; Final Guidance for Industry and...
...The device manufacturer is responsible for ensuring that the product development methodologies used by the OTS software.....Such tools should have a degree of quality no less than the software product they are used.....Device manufacturers are responsible for the adequacy of the software used in their devices, and used to produce..
http://www.fda.gov/cdrh/comp/guidance/938.html (score=85)

Substance
...individual batches of the drug substance used in animal and clinical testing, Drug.....relation to the amount of crude product, whether it is filtered while hot, whether a.....testing used to monitor its identity, strength, quality, and purity. A description of the..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=83)

Pediatric Rule
...that are dangerous to health when used in the manner prescribed, recommended, or suggested.....recognizes that, in some cases, a change to an approved product, particularly a new.....that are dangerous to health when used in the manner prescribed, recommended, or suggested..
http://www.fda.gov/cder/guidance/pedrule.pdf (score=81)

...PRODUCT CONCERNS, PRODUCT CHARACTERISTICS AND USES, REQUIRED INDUSTRY ACTIONS, AND REQUIRED REGULATORY.....The agency considers structural tissue to be used for a homologous function when used to replace an analogous structural.....The agency considers cellular products to be used for a homologous function when they are used to perform their native function, and..
http://www.fda.gov/cber/gdlns/celltissue.txt (score=81)

CBER - Workshop on Standards for Inactivation and Clearance of Infectious...
...licensed product, but was made in manner similar to the method used to make product A and was licensed.....We have an animal derived product being used in human and physician oversight of the undoubtedly, in.....Viral filters are being widely used now and they're now even being used in recombinant products and recombinant products just..
http://www.fda.gov/cber/minutes/infcagnt1025.htm (score=77)

PHS Guideline on Infectious Disease Issues in Xenotransplantation
...product recipient, even if the xenotransplantation product was previously rejected or.....suitability of any animals as sources of nonhuman animal live cells, tissues or organs.....cells, tissues, or organs from nonhuman animal sources and are used for..
http://www.fda.gov/cber/gdlns/xenophs0101.pdf (score=77)

Safety and Effectiveness of New Drugs & Biological Products in Pediatric...
...Where there is evidence that a drug product is widely used in pediatric patients, failure to provide.....The type of formulation needed would vary depending on the age group in which the product were to be used and.....A partial waiver would be appropriate where, for example, the product was likely to be used in substantial numbers..
http://www.fda.gov/cder/guidance/pedrule.htm (score=77)

Compliance Program - Inspection of Plasma Derivatives of Human Origin, 7342.006
...Water used to rinse product containers after heat treatment should also be controlled for.....Water used to heat-treat and to rinse product containers after heat-treatment must be suitable for its intended use and.....Each plasma fraction is enriched in specific protein components and is used for a..
http://www.fda.gov/ora/cpgm/42_006.html (score=75)

Las Vegas Injury Lawyer