Guidance for Industry
...preparation of rubber stoppers should meet appropriate quality control criteria and not.....regardless of acceptance criteria, would be a signal of an adverse trend on the aseptic.....methods separately, as appropriate, and then brought together.2 Because there is no..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=100)

Guidance for Industry: Manufacturing, Processing, or Holding Active...
...the batch selection criteria and analytical data that will be evaluated to determine.....FDA expects appropriate CGMPs to be applied to all steps of an API manufacturing process.....should comply with appropriate specifications and not alter API quality beyond its..
http://www.fda.gov/cder/guidance/1289dft.pdf (score=99)

Guidance for Industry
...preparation of rubber stoppers should meet appropriate quality control criteria and not.....regardless of acceptance criteria, would be a signal of an adverse trend on the aseptic.....methods separately, as appropriate, and then brought together.2 Because there is no..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=99)

FR Doc 03-5401
...These requirements, if finalized, would ensure that manufacturers establish and use appropriate.....The working group issued a report that discussed the selection of the most appropriate and.....criteria for establishing appropriate specifications. The proposal would further require..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5401.html (score=98)

Premarket Assessment of Pediatric Medical Devices - Guidance for Industry...
...If you cannot identify the appropriate FDA staff, call the appropriate number listed on.....In developing the guidance, we carefully considered the relevant statutory criteria for.....In summary, FDA believes clinical data are appropriate when any of the following..
http://www.fda.gov/cdrh/mdufma/guidance/1220.html (score=98)

CGMP Regulations
...The statistical quality control criteria shall include appropriate acceptance levels and/or appropriate rejection.....In such instances a written record of the program shall be maintained along with.....appropriate criteria such as statistical criteria for component variability, confidence levels, and..
http://www.fda.gov/cder/dmpq/cgmpregs.htm (score=97)

Document
...criteria as defined in part 50, subpart D, due to age, to give consent themselves, Section.....products are appropriate. minor change to clarify that the assent.. to clinical.....By letter dated December 23, 1999, Class B or C criteria of the Natural.. Utah sent to us..
http://www.fda.gov/OHRMS/DOCKETS/98fr/042401a.pdf (score=97)

FR Doc 03-29448
...Given the absence of these types of criteria for dietary guidance statements, how can FDA.....Are there specific circumstances when IFRs should or should not be considered appropriate.....Here again, additional flexibility may be appropriate for considering health claims for..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-29448.htm (score=97)

STATEMENT OF LINDA A. SUYDAM, D.P.A., SENIOR ASSOCIATE COMMISSIONER
...Advisory committees also advise the Agency on general criteria for evaluation, of broad.....All nominations in response to the Federal Register notice must be submitted to the.....If any of the above criteria apply to a candidate's appointment/reappointment, an..
http://www.fda.gov/ola/2000/advcomm.html (score=97)

Document
...at 20 percent sweat reduction, met one of the extra effective criteria. active ingredient.....appropriate effectiveness data and an .. aluminum in the blood enters the brain, VerDate.....according to the Panel's criteria. having subjects do a word definition test .. two..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.pdf (score=97)

March/April 1999 FDA Veterinarian Newsletter
...The evaluation criteria for Type C Medicated feed methods are the same whether the methods.....The test method must be in an SOP format supported by appropriate validation data, and.....If the data show the method can meet CVM performance criteria, the method is approved..
http://www.fda.gov/cvm/index/fdavet/1999/march.html (score=96)

Review of F-18 Fluoro-2-Deoxyglucose (F-18 FDG) Positron Emission Tomography...
...FDA has been working with the PET community to develop appropriate criteria and procedures to evaluate.....This study does not provide information on selection criteria, interpretative criteria, and why the protocol called.....This study’s endpoint of comparing PET to CT was not appropriate because it used F-18 FDG..
http://www.fda.gov/cder/regulatory/pet/fdgoncologyfinal.htm (score=96)

Guideline for Quality Assurance in Blood Establishments
...scientifically sound and appropriate specifications, standards, to assure that blood and.....The statistical quality control criteria shall include..appropriate acceptance levels and.....tests and donor suitability criteria. In addition, the FDA..has intensified its oversight..
http://www.fda.gov/cber/gdlns/gde_qa.pdf (score=96)

American National Red Cross/Biomedical Services: Adverse Determination...
...ja2 be reliably scored using appropriate criteria and that the scoring process used to develop the Job.....criteria labeled as leukoreduced and antigen-positive products labeled as antigen-negative.....appropriate priority to resolving such problems. Additionally, neither the Job Aid nor the..
http://www.fda.gov/ora/frequent/letters/ARC_ADLetter_2604.html (score=96)

Questions and Answers
...FDA intends to reserve adequate resources to ensure appropriate oversight of products that.....We are developing appropriate criteria to assist in the decision making process. It is envisioned that.....The appropriate expertise, as necessary, will be incorporated into the team to achieve the..
http://www.fda.gov/cder/gmp/gmp_q&a.htm (score=96)

Guideline for Efficacy Evaluation of Canine/Feline Anthelmintics
...There should be equal numbers of treated and untreated animals, but with appropriate.....appropriate criteria. Animals within each replicate should have similar prior exposure to helminth.....In some instances, the above method may not be appropriate and other methods of..
http://www.fda.gov/cvm/guidance/guideline36.html (score=96)

...FDA invites comment on appropriate criteria for IRBs to use in assessing when a clinical investigation.....These criteria are the same for initial review and continuing review and include a.....Nevertheless, FDA has historically relied on the HHS regulations to provide appropriate..
http://www.fda.gov/OHRMS/DOCKETS/98fr/042401a.htm (score=96)

Draft Guidance for Industry and FDA Review Staff: Collection of Platelets by...
...We consider the recommendations in this guidance document to provide appropriate criteria for a.....If you cannot identify the appropriate FDA staff, call the appropriate number listed on.....21(c), plateletpheresis donors must meet donor suitability criteria described in the..
http://www.fda.gov/cber/gdlns/plateletauto.htm (score=96)

Federal Register: General Requirements for Blood, Blood Components, and...
...Government Reform and Oversight, failure to satisfy suitability criteria.. In 1988, PHS.....appropriate medical referral. In the past, public, FDA has convened a number of.. In 1985.....results or donor suitability criteria. further spread of infection. rule under the..
http://www.fda.gov/cber/rules/defdonor.pdf (score=96)

FR Doc 03-14140
...The agency needs appropriate effectiveness data and an appropriate USP-NF monograph.....Thus, these studies showed that the 25-percent aluminum chlorohydrate met the Panel's.....The comments argued that if manufacturers can demonstrate by appropriate testing and..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.htm (score=96)

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