MedWatch - Medical Product Safety Information
...product problems that occur after the administration of approved drug and therapeutic.....product safety alerts, Class I recalls, market withdrawals, public health advisories.....Medical Product Safety Information.. MedWatch Safety Information .. Safety Alerts for..
http://www.fda.gov/medwatch/safety.htm (score=100)
CDRH PRODUCT CODE CLASSIFICATION DATABASE
...The Product Code assigned to a device is based upon the medical device product.....This database contains device names and their associated product codes. The name and product code identify the generic.....Product Code Classification Database.. The Product Classification Database contains medical device names and associated information..
http://www.fda.gov/cdrh/prodcode.html (score=85)
Electronic Product Radiation Control
...Technical Electronic Product Radiation Safety Standards Advisory Committee (TEPRSSC.....Summary of Electronic Product Radiation Control.. Radiation Control Law .. Overview of.....Nationwide Evaluation of X-ray Trends (NEXT) Product/Program Areas.. Medical Products..
http://www.fda.gov/cdrh/radhlth/index.html (score=83)
Approvals of FDA-Regulated Products
...At the heart of all FDA's medical product evaluation decisions is a judgment about whether.....No regulated product is totally risk-free, so these judgments are important. FDA will.....product they want to put on the market is safe and effective. FDA does not develop or test..
http://www.fda.gov/opacom/7approvl.html (score=82)
FDA Recalls, Market Withdrawals and Safety Alerts
...This list includes the most significant product actions of the last 60 days, based on the.....Issues Allergy Alert on Undeclared Sulfites in Product (May 4, 2005) Edwards Fine Foods.....Sween Company Expands Voluntary Product Recall (March 18, 2005) FDA Issues Nationwide..
http://www.fda.gov/opacom/7alerts.html (score=80)
Recalls, Market Withdrawals and Safety Alerts Archive
...This archive includes the most significant product actions, based on the extent of.....December 19, 2003) Hansen Beverage Company Issues a Safety Alert and Product Recall of its.....Recall of Traditional Basil Pesto Product (February 20, 2004) Fresh Food Concepts Recalls..
http://www.fda.gov/oc/po/firmrecalls/archive.html (score=79)
us_rhophylac_300_HPL
...The product potency is..expressed in international units by comparison to the World Health.....safety of this product with respect to potential contamination with blood borne pathogens.....Nevertheless, the product may contain trace amounts of IgA. Although anti-D immunoglobulin..
http://www.fda.gov/cber/label/igivzlb021204LB.pdf (score=78)
CBER Licensed Product Approval Information
...This list includes product applications for which we have approval documents available.....To locate specific approval information by product tradename, select the Licensing Actions.....Product approval information is arranged alphabetically by the proper name of the product..
http://www.fda.gov/cber/efoi/approve.htm (score=92)
GUIDE TO INSPECTIONS OF COSMETIC PRODUCT MANUFACTURERS
...The purpose of cosmetic inspections is to assure cosmetic product safety and determine.....Report in the EIR the name of each chlorofluorocarbon-containing aerosol product which is.....During all stages of manufacture and storage the chlorofluorocarbon-containing aerosol..
http://www.fda.gov/ora/inspect_ref/igs/cosmet.html (score=83)
Orphan Product Designation
...The combination of the product to treat the rare disease or condition must meet certain.....Orphan designation qualifies the sponsor of the product for the tax credit and marketing.....A marketing application for a prescription drug product that has been designated as a drug..
http://www.fda.gov/orphan/designat/ (score=81)
Electronic Product Radiation Control
...Technical Electronic Product Radiation Safety Standards Advisory Committee (TEPRSSC.....Electronic Product Radiation Control.. Key Topics... Electronic Submission Software.....Summary of Electronic Product Radiation Control.. Radiation Control Law .. Overview of..
http://www.fda.gov/cdrh/comp/eprc.html (score=81)
Viagra
http://www.fda.gov/cder/consumerinfo/viagra/ (score=81)
Information on Marketing a Pet Food Product
...These include more specific requirements regarding product names, flavor designations.....product is free of any viable microorganisms. Producers must file acceptable processing.....proper identification of the product as a pet food; net quantity statement (weight, volume..
http://www.fda.gov/cvm/index/consumer/market.htm (score=80)
MedWatch - How to report serious adverse events
...Medical Product Problems to the FDA.. A Message About HIPAA Compliance for Reporters to..
http://www.fda.gov/medwatch/how.htm (score=79)
FDA Drug and Device Product Approvals
...1994 Drug and Device Product Approvals-WordPerfect Format (691 KB) 1993 Drug and Device.....FDA Drug and Device Product Approvals.. This publication includes a list of Drugs, Medical.....product legacy information from February 1991 through September 1996. Beginning September..
http://www.fda.gov/cder/da/ddpa.htm (score=79)
FDA, Regualtory Delegations of Authority
...The Director, OCP, and the Product Assignment Officer, OCP, OIASI, OC, are authorized to.....product as a drug, biological product, device, or combination product subject to section.....Product Classification Officer, OCP, OIASI, as product jurisdiction officer are authorized..
http://www.fda.gov/smg/1410_701.htm (score=78)
...adverse reactions and product quality or use problems, including medical product errors.....Before a product is approved, the FDA sets the standards for a medical product that will.....Failure Mode and Effects Analysis-A Way to Eliminate Medical Product Errors Safety Risk..
http://www.fda.gov/oc/workshops/errorsum.htm (score=77)
Electronic Product Radiation Control
...Technical Electronic Product Radiation Safety Standards Advisory Committee (TEPRSSC.....Electronic Product Radiation Control.. Key Topics... Optional Electronic Submission.....Summary of Electronic Product Radiation Control.. Radiation Control Law .. Overview of..
http://www.fda.gov/cdrh/radhlth/ (score=77)
E.A. Sween Company Implements Voluntary Product Recall
...The product has been available for purchase in the refrigerated section of select.....Routine sampling of the product revealed that a single sandwich in this lot contained.....This specific lot of product has been recalled as a precautionary measure. Customers are..
http://www.fda.gov/oc/po/firmrecalls/EASween03_05.html (score=77)
ORA/OE/DCMO - Guidance for Industry: Product Recalls, Including Removals and...
...If the recall is due to failure of the product to meet product specifications, provide the specifications.....In a situation where the product may pose a significant health hazard and recalled product.....been shipped or sold recalled product because it was sold to them within the applicable..
http://www.fda.gov/ora/compliance_ref/recalls/ggp_recall.htm (score=77)
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