FDA Data Council Initiatives
...FDA Data Council Initiatives.. FDA Data Council.. Standards Development.. Electronic.....Annotated ECG Waveform Data.. Stability Data.. Clinical and Animal Study Data.. MedWatch.....FDA Data Council Initiatives.. 2/24/2003.. Click here to start .. Table of Contents..
http://www.fda.gov/cder/regulatory/ersr/2003_02_13_update/index.htm (score=100)

Guidance for Industry: E5 … Ethnic Factors in the Acceptability of Foreign...
...The ICH guidance E5 Ethnic Factors in the Acceptability of Foreign Clinical Data was.....E5 says, in general, that if the data developed in one region satisfy the requirements for.....region, but the amount of additional data called for is a matter of judgement on the part..
http://www.fda.gov/cber/gdlns/iche5ethnic.pdf (score=98)

CBER - Simian Virus 40 (SV40:) A Possible Human Polyomavirus Workshop
...So, most of the data, most of the serological data that we had, could be, perhaps, explained as a result of cross.....And, we heard compelling data on both sides of that question, all from good labs, and I.....Well, just to rehearse some of the data on whether SV40 is an infectious agent for humans..
http://www.fda.gov/cber/minutes/sv40012897.htm (score=97)

Document
...preferential subject perception data, four and five as the baseline, and the .. agency has.....supporting data or specific examples of .. agency doubts that any chromatographic.....appropriate effectiveness data and an .. aluminum in the blood enters the brain, VerDate..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.pdf (score=97)

Document
...circumstances, disclosing any data or.. other cases, such as some oral vaccines, developer.....data or information about the identity.. genes that encode resistance to an antibiotic as.....regulation, a notifier provides data or other.. 15 A report that describes the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/011801a.pdf (score=97)

...Well, we look first to animal data, in vitro data, to give us some indication of where to look, what.....Leroy will present the clinical efficacy data, including the additional data on resistant.....And Aventis submitted to the agency an amendment in July of 2002 with the data from those..
http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3919T1.htm (score=97)

FR Doc 03-14140
...Extended duration of effect claims have been placed in Category I based on data submitted.....The agency would consider these terms if data are provided to show that consumers would.....Although the comments did not submit any data to show that antiperspirant drug products..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.htm (score=97)

Human Subject Protection; Foreign Clinical Studies Not Conducted Under an...
...Submit your comments, will examine data from such a study. application submitted under.....IEC2 before initiating a study, solely on foreign clinical data is .. investigations in.....elsewhere will protect the rights, safety, data such as hospital or other .. conformed to..
http://www.fda.gov/cber/rules/forclinstud.pdf (score=97)

ATDEPARTMENT OF HEALTH AND HUMAN SERVICES
...So, we think this is an extremely important piece of data and we wanted to have sufficient.....I appreciate the opportunity today to present our data on the efficacy and safety of our.....Through the use of external data review committees and rigorous, standardized assessments..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3792t2.htm (score=97)

Document
...Submit your comments, will examine data from such a study. application submitted under.....IEC2 before initiating a study, solely on foreign clinical data is .. investigations in.....elsewhere will protect the rights, safety, data such as hospital or other .. conformed to..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-13063.pdf (score=97)

TO:
...This submission provides data and an evidence-based assessment of acetaminophen efficacy.....Review of metabolism, pharmacokinetic, and prospective clinical trial data confirms that.....These findings, integrated with the data from the meta-analysis and placebo-controlled..
http://www.fda.gov/ohrms/dockets/ac/02/briefing/3882B1_13_McNeil-Acetaminophen.htm (score=97)

Document
...adverse events, protocol amendments, presented data demonstrating that.. these.....to prevent the introduction, confidentiality of data and information.. the potential risk.....biological activity, immune response, of certain data and information related to an.. care..
http://www.fda.gov/OHRMS/DOCKETS/98fr/011801b.pdf (score=97)

1
...16 data, I want to, with the use of a few pictures, 17 consider what a PASI 50 and PASI 75.....17 infections when counts were above 250, 46 percent, 18 the data suggest that lower T.....20 data to the FDA that have resolved that, 21 demonstrating that this was inference in..
http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3865T1.htm (score=97)

Guidance for Industry: Addendum to E2C Clinical Safety Data Management:...
...The addendum report should summarize the safety data received between the data lock point of the most recent PSUR.....The PSUR is a practical and achievable mechanism for summarizing interval safety data.....When relevant, data relating to a particular indication, dosage form, or dosing regimen..
http://www.fda.gov/cber/gdlns/ichclinsafety.htm (score=97)

CBER - Workshop on Development of Donor Screening Assays for West Nile Virus
...There is a very large body of inactivation data that exists for BVDV, and these data should provide assurance that West Nile.....This is the data using the same energy points that we had chosen from the previous BVDV.....I am just going to be talking about the published data on viruses that are close relatives..
http://www.fda.gov/cber/minutes/wnv110502.htm (score=97)

...We are pleased that we are able to present data which demonstrates clinical benefit with.....The mortality alpha was further reduced by the interim analysis carried out by the Data.....Now, ejection fraction was monitored by echo, and these are the ejection fraction data..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3793t1.htm (score=97)

ICH; Guidance for Industry: E5 – Ethnic Factors in the Acceptability of...
...E5 says, in general, that if the data developed in one region satisfy the requirements for.....for development of data to occur simultaneously in various regions, rather than.....There might also be situations in which the region would consider further safety data..
http://www.fda.gov/cber/gdlns/iche5ethnic.htm (score=97)

Appendix 3
...There is no reason to standardize by the standard deviation, which makes the data less.....Is the FDA data on the products that contain ephedra based It could be based on the label.....Inclusion of Non-Scientific Adverse Event Reports Invalidate Animal and laboratory data..
http://www.fda.gov/OHRMS/DOCKETS/98fr/95n-0304-bkg0003-ref07-21-Appendix3.pdf (score=97)

Preparing Data for Electronic Submission in ANDAs
...This guidance is intended to provide assistance to applicants submitting data in.....This guidance contains a glossary of the terms related to submitting ANDA data in.....OGD currently has a process that allows the submission of some types of data and certain..
http://www.fda.gov/cder/guidance/3223fnl.htm (score=97)

FDA Releases Acrylamide Data and Final Acrylamide Action Plan
...These data expand the agency's ability to assess the extent to which this chemical is.....The new data are consistent with previous findings showing higher levels of acrylamide in.....Most of the new data were taken from samples used as part of the FDA's FY03 Total Diet..
http://www.fda.gov/bbs/topics/news/2004/NEW01040.html (score=97)

Las Vegas Injury Lawyer