Navigation Links
FDA Proposes New Drug Labels for Pregnant Women
Date:5/28/2008

New drug labels would include three sections devoted to pregnancy and breast-feeding. The first section, called the "Fetal Risk Summary," would describe what's known about the effects of a drug on the fetus and whether the risk is based on results of animal studies or human studies.

The second section, called "Clinical Considerations," would include information about effects associated with the drug if it were taken before a woman knows she is pregnant. This section would also outline risks of the disease to the mother and baby, dosing information and how to address complications.

The final section, called "Data," would describe in detail the available information about the drug's use in humans and animals studies used in developing the "Fetal Risk Summary."

The breast-feeding section of the label would use the same format as the pregnancy section and provide information about using the drug while nursing, Kweder said.

The FDA began work on redesigning labels of prescription drugs' effects during pregnancy and breast-feeding in 1997. The proposed changes announced Wednesday will undergo a review process, with the agency receiving comments from various stakeholders. Once that review has been completed, the FDA will incorporate the comments and come up with a final version of the labels. This process could take up to one year to finish, officials said.

Once the rule takes effect, new drugs would have to conform immediately to the revised labeling standard, Kweder said. For older drugs, the label requirements would be phased in over time. It will take several years for all drugs to comply with the new label standard, she said.

More information

For more on prescription drugs and pregnancy, visit the U.S. Department of Health & Human Services.



SOURCES: May 28, 2008, teleconf
'/>"/>

Copyright©2008 ScoutNews,LLC.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Brandes Proposes 130 yen per Share Dividend and 10 Million Share Buyback Program for Ono Pharmaceutical Annual Meeting
2. Navigenics Proposes Standards for Personal Genomics Services, Coupled With Prospective Outcomes Studies, to Safeguard Consumers
3. Governor Rendell Proposes County Grants to Combat West Nile Virus, Protect Public Health
4. CardioDynamics Board of Directors Proposes Reverse Split 1:7 of Companys Shares
5. National Patient Safety Foundation Proposes Universal Patient Compact
6. HRSA Proposes Rule to Revise, Combine HPSAs, MUPs
7. California Stem Cell Agency Proposes Unjustified Increase in Top Salary Ranges
8. Lake Forest Hospital Proposes a New Health Care System in Lake County
9. Carnegie Mellon neuroscientist proposes new theory of brain flexibility
10. FDA Proposes New Rules for Sunscreens
11. Alcohol Awareness Month: Distilled Spirits Council Urges Government Support for Standard Drink Information on Labels
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/20/2014)... 20, 2014 Today, Balfleet.com, one of ... Christmas Sale, offering 50%-70% off on its Mother ... , The mother of the bride dresses from Balfleet.com ... is 24/7 accessible and takes pride in providing high ... “We are offering great discounts on our mother of ...
(Date:12/19/2014)... It’s very easy to become overwhelmed with the holidays ... the wayside until Christmas and the New Year are over. ... that burning desire to just escape it all and get ... Telluride with a no-fuss, affordable package. Montrose Days Inn will ... and ensure that all accommodations are met. Plus, everyone has ...
(Date:12/19/2014)... Florida (PRWEB) December 19, 2014 Sub Zero ... to sponsor a blood drive Sunday the 28th from 2pm-6pm ... Road & Sawyer Road in Sarasota, FL. , Inquiries regarding ... thank you for participating in the donating process, Sub Zero ... free flash frozen, custom ice cream. , About Sub Zero ...
(Date:12/19/2014)... (PRWEB) December 19, 2014 ... dedicated to developing educational events, tools and resources ... Rouxbe Cooking School , the world’s leading online ... prescription every human being needs: Culinary Rx. As ... cooking course, Culinary Rx, scheduled for debut spring ...
(Date:12/19/2014)... Santa Rosa, CA (PRWEB) December 19, 2014 ... 2x4 and 5x5 SuperClone Rooms. SuperCloset continues to offer ... grow solutions. Pair one of the new SuperClone Rooms ... truly professional, perpetual, and turnkey indoor hydroponic grow room ... cloner in the world, SuperCloset’s SuperPonic SuperCloner 50 ...
Breaking Medicine News(10 mins):Health News:Balfleet.com is Offering 50%-70% Off of its Mother of the Bride Dresses 2Health News:Days Inn Montrose Colorado Delivers Last Minute Holiday Season Ski Getaway Accommodations 2Health News:Shark Tank’s Sub Zero Ice Cream Sponsors Blood Drive 2Health News:The Plantrician Project and the Rouxbe Cooking School Join Forces to Develop Culinary Rx – a Plant-Prescription Course 2Health News:The Plantrician Project and the Rouxbe Cooking School Join Forces to Develop Culinary Rx – a Plant-Prescription Course 3Health News:The Plantrician Project and the Rouxbe Cooking School Join Forces to Develop Culinary Rx – a Plant-Prescription Course 4Health News:SuperCloset Continues to Innovate with New Complete Indoor Grow Room Packages, The SuperClone Rooms are the Newest Addition to the Award Winning SuperRoom Lineup 2
... Massachusetts General Hospital (MGH), together with a coalition of ... world,s largest registry of patients who have had optical ... an intravascular imaging technology that researchers hope will give ... plaques that cause heart attacks and sudden cardiac death. ...
... finds , THURSDAY, March 25 (HealthDay News) -- More than ... said that they drank alcohol in the past month, according ... The analysis of 2006-2008 data from the National Survey on ... rates were as high as 40 percent in some states, ...
... The effectiveness of ordinary surgical masks as opposed to ... H1N1 influenza virus has been the subject of debate. ... issue of Clinical Infectious Diseases, available online ... as effective as respirators in this regard. ...
... ... strategy to treat motor symptoms in rats with a disease designed to mimic Parkinson,s disease. ... San Francisco, CA (Vocus) ... symptoms in rats with a disease designed to mimic Parkinson,s disease., , , , ,The ...
... This press release is available in French . ... a previously hidden channel to attack leukemia and other cancer ... Journal of Biological Chemistry . The findings from the Universit ... way doctors treat cancer patients. "We found a gateway, ...
... survey finds , THURSDAY, March 25 (HealthDay News) ... likely to be chronically offline: they use the Internet ... , The survey, conducted by the Pew Internet & ... published online March 24, found that just 62 percent ...
Cached Medicine News:Health News:Mass. General Hospital to create registry for coronary optical coherence tomography 2Health News:Underage Drinking Soars in U.S. 2Health News:Novel Parkinson's Treatment Strategy Involves Cell Transplantation 2Health News:Novel Parkinson's Treatment Strategy Involves Cell Transplantation 3Health News:Novel Parkinson's Treatment Strategy Involves Cell Transplantation 4Health News:New gateway to treat leukemia and other cancers 2Health News:Chronic Disease Linked to Less Internet Usage 2
(Date:12/19/2014)... 19, 2014  Newport Corporation (NASDAQ: ... has joined the company,s Board of Directors.  Dr. ... a director of Evans Analytical Group, a leading ... analytical services to companies in a wide range ... Evans Analytical Group, Dr. Kadia spent nine years ...
(Date:12/19/2014)... 2014 Breckenridge Pharmaceutical, Inc. announced today that ... Laboratories Pvt. Ltd. ( Hyderabad, India ) ... new ANDAs.  Under the terms of the agreement, MSN ... Breckenridge for the U.S. market, and Breckenridge will market ... MSN have agreed to develop an oral antibiotic with ...
(Date:12/19/2014)... , Dec. 19, 2014 In ... research and marketing communication tools are essential for ... competitive – consequently consumers, desires, preferences, and unmet ... environment, market research groups across all industries are ... communication tools. However, the adoption of new market ...
Breaking Medicine Technology:Siddhartha Kadia, Ph.D. Joins Board of Directors of Newport Corporation 2Breckenridge Pharmaceutical signs Multi-Product Generic Agreement with MSN Laboratories Pvt. Ltd. 2Study Uncovers New Tools and Techniques for Understanding Consumer Decision Making 2
... SKILLMAN, N.J., Feb. 7, 2011 ConvaTec, a world-leading ... and hospital care, today announced the appointment of several ... Nino Pionati has been appointed President, Intercontinental in ... Latin America and Canada. These markets continue to be ...
... 2011 BioSpecifics Technologies Corp. (Nasdaq: BSTC ... first in class collagenase-based products, today announced that its ... "Rights Agreement"), adopted May 14, 2002 and previously amended ... increases the ownership threshold for determining "Acquiring Person" status ...
Cached Medicine Technology:ConvaTec Announces New Appointments to Leadership Team 2
... NGAL (neutrophil gelatinase-associated lipocalin, lipocalin-2) is a ... predicting acute renal failure with a >90% ... especially in urine, as early as 2 ... an ideal diagnostic marker for acute renal ...
... quality control material used for monitoring the ... on CO-Oximeter instrumentation. It provides an alternative ... the human physiologic range for tHb, O2Hb, ... three (3) levels for monitoring analyzer performance ...
... 233 is an assayed quality ... the measurements of total hemoglobin ... instrumentation. It is available in ... analyzer performance at varying points ...
... QC 623 is an assayed quality control material ... available in four (4) levels for monitoring analyzer ... It may be used on multiple test analyzers ... the Radiometer 600). QC623 is also for use ...
Medicine Products: