|
FDA News is a premier provider of both US and international
regulatory, legislative, and business news and information for
executives in industries regulated by the US Food and Drug
Administration and the European Commission.
FDA News produces newsletters, books, reports and conference
documents which pharmaceutical and medical device professionals
can use to stay in compliance with international standards and
the FDA's regulations. The experienced staff of FDA News provide
this timely, insightful and practical information.
Sources:
The BioDefense Funding Report (weekly - 50 issues per year)
helps you find and win biodefense grants and contracts from
basic research to medical devices to protective devices and
drugs.
Clinical Trials Advisor (bi-weekly - 24 issues per year) helps
pharmaceutical manufacturers, clinical researchers, IRBs and
investigators improve clinical trial operations and GCP
compliance. It covers the latest regulatory and international
news, and practical advice for maximizing your clinical
investments.
Devices & Diagnostics Letter (weekly - 50 issues per year) is
for leaders in the device and diagnostics industries who need
to stay in compliance and avoid costly design and production
mistakes. It provides the latest regulatory news, including
Part 11 compliance, software validation rules and other pre-
and post-market requirements.
Drug GMP Report (monthly - 12 issues per year) gives in-depth
coverage of technical quality control issues that affect drug
development and production processes. It provides concise,
easy-to-read explanations of key regulatory trends and advice
to make FDA regulatory compliance easier.
Drug Industry Daily (daily during the working week) covers
what is happening on Capitol Hill and at the FDA, FTC, HHS,
NIH and other key agencies and decision making bodies that
affect the pharmaceutical industry. It reports on topics such
as patent exclusivity, DTC advertising, medication errors,
program funding, FDA appropriations, bioterrorism, warnings,
recalls, approvals and more.
The Food & Drug Letter (biweekly - 24 issues per year) provides
reliable, in-depth analysis of how FDA's regulations and
procedures will affect your current decisions and long-term
plans, and gives you in-depth interpretation to tell you why
FDA is making or proposing revisions. This can help you chart
your course for electronic signatures, drug and device GMPs,
labelling, FDA inspections and much more.
Generic Line (biweekly - 24 issues per year) is devoted to the
generic drug industry, and covers the growing interaction among
brand-name companies and generic makers. It includes the latest
cooperative agreements, plus business, regulatory, and
legislative changes that affect your business decisions.
The GMP Letter (monthly - 12 issues per year) covers the FDA's
interpretation and enforcement of the Quality System Regulation
(QSR). It reports on key regulatory developments, with tips on
what you can do to prepare for FDA inspections, and proven ways
to improve design control procedures and create more effective
GMP training programs.
Part 11 Compliance Report (bi-weekly - 24 issues per year)
provides definitive insights for complying with the complex
and still-evolving 21 CFR Part 11 rule. It has comprehensive
coverage of requirements for electronic submissions and
signatures, guidance document interpretations, implementation
best practices, FDA enforcement actions and more.
Pharmaceutical Corporate Compliance Report (available to end of
March 2005) gives insight into the full range of compliance
risks and responsibilities. From drug pricing for government
purchasers to patient privacy, from corporate accounting and
financial reporting to human subject research protection, it
covers concerns about non-FDA compliance.
Washington Drug Letter (weekly - 50 issues per year) provides
concise summaries of FDA regulatory changes and key legislation
that affects prescription and OTC drugs. It keeps you up-to-date
on pre-approval and post-approval issues that directly impact
your operation, such as electronic submissions, paediatric
studies, user fees and NDA submissions, drug reimportation,
post-market surveillance priorities, GMPs, international
harmonization and more.
Sample document from FDAnews Device Daily Bulletin
AN - Accession number & update:
0001878040 20050329.
TI - Title:
Boston Scientific Completes Enrollment for ATLAS Trial.
SO - Source:
FDAnews Device Daily Bulletin, 22 February 2005, vol. 2, no.38.
TX - Text:
Boston Scientific has completed enrollment in its ATLAS clinical
trial, a global, multicenter, pivotal study designed to support
FDA approval of the Taxus Liberte stent system.
The trial is assessing the safety and efficacy of a slow-
release dose formulation paclitaxel-eluting Taxus Liberte stent
system for the treatment of coronary artery disease. ATLAS has
enrolled 872 patients at 72 sites in the U.S., Canada,
Australia, New Zealand, Singapore and Hong Kong. The primary
endpoint for the study is target vessel revascularization at
nine months.
Boston Scientific received the CE Mark for the bare metal
Liberte stent system in December 2003 and plans to launch the
Taxus Liberte system in Europe later this year. The Taxus
Liberte system was launched in 18 other international markets
in January.
(http://www.fdanews.com/pub/ddl).
DE - Descriptors:
Market sectors: MEDICAL-EQUIPMENT; CARDIOVASCULAR-ILLNESSES;
MEDICAL-AND-HEALTH;
Event names: MAJOR-CORPORATIONS;
Geographic names: MASSACHUSETTS; USA; AMERICAS; NEW-ENGLAND;
NORTH-AMERICA.
CO - Company names:
ATLAS.
LG - Language:
English.
PT - Publication type:
Newswire.
CP - Copyright:
Copyright (c) 2005 Washington Business Information, Inc.
AV - Availability:
Supplier number: 3252.36282.a
Full text; Lead paragraph.
NT - Notes:
Journal code: FDDB
Word count: 128.
YR - Publication year:
2005.
DT - Publication date:
20050222.
LE - Length:
1,442 Characters, approximately 1 PC screen.
OC - Occurrences:
PARAGRAPH
YR (1)
DT (1).
Sample document from The GMP Letter
AN - Accession number & update:
0001859059 20050329.
TI - Title:
Response is Key to Mitigating Effects of Inspectional
Observation.
SO - Source:
The GMP Letter, 03 February 2005, vol. 1, no. 301.
TX - Text:
A carefully crafted response to an FDA Form 483 observation
is key to minimizing the impact of a negative assessment, but
communications failures early in the process can expose an
offending company to serious enforcement actions, one
consultant told GMP.
One bad inspection can damage the company's reputation with
the FDA for years, Gordon Richman, vice president and general
counsel of consulting fIrm EduQuest, said during an FDA
Information Management Summit sponsored by FDAnews.
An insufficient response to a 483 observation may lead the
FDA to draw negative conclusions, and the agency will likely
consider the response inadequate and will not seek
clarification, Richman added. Instead, the FDA could
implement further enforcement action, he said. Implementing
short-term corrective actions immediately may enable the firm
to avoid a 483 observation.
If a 483 is issued, try to resolve the issues immediately to
convince the FDA that the firm is paying attention and will
fix the problems noted by the investigator, Richman said,
with an eye toward making sure the agency understands that no
further action is needed.
To regain the agency's confidence, demonstrate that the firm
understands the issues and the FDA's concerns about company
procedures, and show that the organization is responsible
and trustworthy, Richman said. Prove to the FDA that your
company will achieve and maintain compliance and that an
effective quality system is in place.
A convincing response should discuss ... (article continues)
LG - Language:
English.
PT - Publication type:
Newswire.
CP - Copyright:
Copyright (s) 2005 Washington Business Information, Inc.
AV - Availability:
Supplier number: 3165.35407.a
Full text; Lead paragraph.
NT - Notes:
Journal code: THGL
Word count: 547.
YR - Publication year:
2005.
DT - Publication date:
20050203.
LE - Length:
3,979 Characters, approximately 2 PC screens.
OC - Occurrences:
PARAGRAPH
SO (1).
Label/description Example
AN Accession number 1_: 0001878040.AN.
& update 2_: 20050329.AN.
- see also LIMIT options -
TI Title 3_: VIOXX ADJ RECALL.TI.
SO Source* 4_: FOOD WITH DRUG.SO.
or 5_: SO=GENERIC-LINE
or for Volume 6_: VOLUME=3
or for Issue 7_: ISSUE=12
TX Text 8_: FORM WITH 438.TX.
LD Lead paragraph 9_: BIOSANTE AND ESTRADIOL.LD.
T1 Main text (exc. lead para) 10_: SERONO AND HARS.T1.
DE Descriptors* 11_: MEDICAL-EQUIPMENT.DE.
or 12_: MEDICAL ADJ EQUIPMENT.DE.
CO Company names 13_: PFIZER-INC.CO.
or 14_: PFIZER ADJ INC.CO.
LG Language* 15_: ENGLISH.LG.
or 16_: LG=ENGLISH
PT Publication type 17_: NEWSWIRE.PT.
or 18_: PT=NEWSWIRE
CP Copyright 19_: 2005.CP.
AV Availability 20_: FULL ADJ TEXT.AV.
NT Notes (eg. journal code) 21_: FDDB.NT.
or 22_: JC=FDDB
For a list use 23_: ..ROOT JC=
YR Publiction year 24_: 2005.YR.
DT Publication date 25_: 20050126.DT.
or for a date 26_: DATE=20050126
27_: DT=20050126
or for a month 28_: MONTH=200501
or for a year 29_: YEAR=2005
30_: YR=2005
LE Length - display only -
OC Occurrences - display only -
* The ROOT command is especially useful in these paragraphs to
establish, for example, how a descriptor appears in the database.
Initial search to select records 1_: VIOXX
DATE Publication date YYYYMMDD 2_: ..L 1 DATE>20040726
MONTH Publication month YYYYMM 3_: ..L 1 MONTH>200410
YEAR Publication year YYYY 4_: ..L 1 YEAR=2004
UDATE Update date YYYYMMDD 5_: ..L 1 UDATE>20051129
UMONTH Update month YYYYMM 6_: ..L 1 UMONTH WL
200410,200502.
By paragraph, for example show title and source for the first
three items of search number 1:
1_: ..PRINT 1 TI, SO 1-3
By using a named format:
SHORT AN TI SO YR DT
MEDIUM AN TI SO LD T1 YR DT
LONG AN TI SO LD T1 DE CO PT YR DT
ALL AN TI SO LD T1 DE CO LG PT CP AV NT YR DT LE OC
HITS All paragraphs where search terms occur
FREE AN TI DE CO LG PT CP AV NT YR DT LE OC
For example:
2_: ..P ALL 1,3.
..RANK and ..MAP:
This functionality is available in the DE and YR paragraphs.
It is not present for paragraphs LG and PT, as these are
constant across records in the FDAN database (Language is
English, and Publication Type is Newswire).
For a complete guide to FDA News search as BASE-FDAN in the BASE
database.
.
Back to the Datasheet Index Page
© 2008 Dialog DataStar
|