Biomedical Market Newsletter articles from April 2002

Biomedical Market Newsletter archives from April 2002

21 CFR Part 11 Electronic Signatures & Records Compliance Is Still Problematic.(Brief Article)
April 17, 2002... Only 19% of firms can claim they comply Despite a 1997 US Food & Drug Administration (FDA) requirement mandating that medical product manufacturers must comply with the FDA's Rule governing electronic signatures and records (21 CFR Part...

Filing of Shelf Registrations by Biotech Firms Is Expected to Increase in 2002.
April 17, 2002... FEB. 28, 2002 -- Only 36 biotech companies filed a shelf registration during 2001 (nearly half of them occurring 4th qtr), a total that may rise dramatically this year, predicts Joseph A. Smith, Managing Director of Investment Banking at...

Deported Beneficiaries Received Medicare Payments, Says New OIG Study.(Office of the Inspector General)
April 17, 2002... APRIL 03, 2002 -- A new final OIG report, based on a review requested by the Senate Finance Committee, points out that the Medicare program is vulnerable to improper payments for services rendered to deported beneficiaries. The OIG...

Coated Stent Results Are Not As Good As Hoped.
April 17, 2002... APRIL 02, 2002 -- A new drug-eluting stent that helps prevent blood vessels from become closed again after angioplasty, may not last as long as had been hoped, researchers reported in the journal, Circulation.

Proposed Changes To HIPAA Privacy Act.(Health Insurance Portability and Accountability Act of 1996)
April 17, 2002... April 2002 -- The American Medical Group Association has commended DHHS Secretary Tommy G. Thompson for the proposed changes to the DHHS "Health Insurance Portability & Accountability Act of 1996" regulations that were released March 21, 2002.

Many Medicaid Patients Can't Pay For Drugs.
April 17, 2002... APRIL 15, 2002 -- Over 25% of Medicaid beneficiaries can't afford prescription drugs, due to restrictive policies states have established to freeze expenses, says a new report from the Center for Studying Health System Change. Medicaid patients...

CDRH Is Boosting Facility Inspections.
April 17, 2002... MARCH 27, 2002 -- For the rest of FY02 and into FY03, FDA's CDRH will focus most resources on increasing medical product manufacturing facility inspections, plus anti-terrorist activities, especially more import surveillance. CDRH Director...

Sudden Cardiac Death.
April 17, 2002... US Centers for Disease Control & Prevention Atlanta GA Each year in the US, 400,000-460,000 persons die of unexpected sudden cardiac death (SCD) in an emergency department (ED) or before reaching a hospital. Based on the latest US mortality...

Top 500 Cardiology Companies : 2002 Directory of Cardiology Manufacturers & Suppliers.(Directory)
April 17, 2002... Featuring over 600 contacts at over 500 companies & organizations Published exclusively by: Biomedical Market Newsletter[R] O3237 Idaho Place * Costa Mesa CA USA 92626-2207 (714) 434-9500 phone * (714) 434-9755 fax...

FDA Releases Draft Guidance for Industry on Electronic Records; Electronic Signatures, Time Stamps.
April 17, 2002... MARCH 20, 2002 -- The FDA announced today an important new draft guidance for medical manufacturers, "Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Time Stamps." It describes the FDA's current thinking on...

FDA Office of Orphan Products Development FY2001 Accomplishments.
April 17, 2002... MARCH 14, 2002 -- WASHINGTON DC -- Since the Orphan Drug Act was enacted in 1983, the FDA's Office of Orphan Products Development (OPD) has designated 1,152 products to treat many rare conditions. Of these, 228 orphan products are now available...

Heart Attack Patients Have Better Outcomes With Coronary Artery Intervention.
April 17, 2002... American Medical Association Chicago IL APRIL 16, 2002 -- CHICAGO IL -- In hospitals without cardiac surgical facilities, heart attack patients who had artery-opening procedures known as percutaneous coronary interventions (PCI), had a...

Landmark Study Shows Cholesterol-Lowering Drug Taken After Angioplasty Significantly Reduced Risk Of Long-Term Heart Complications.(Lescol)
April 17, 2002... MARCH 19, 2002 -- ATLANTA GA -- 12.6 mln Americans have coronary heart disease, resulting in 1 out of 5 deaths in the US. Every 29 seconds, someone in the US will suffer a coronary event, such as a heart attack. Each year, more than 1 mln...

Clinical Trials Concerns Addressed In Harris Poll.
April 17, 2002... By Harris Interactive (Nasdaq: HPOL) A new Harris Interactive survey reveals why many people are nervous about participating in clinical trials. Only about a third of all adults nationwide are very confident that patients in clinical trials...

List of Orphan Designated Products Approved By FDA For Marketing.
April 17, 2002... As of March 2002 This list of 226 products contains Orphan Designated products that have been approved for marketing. Generic Name: Albendazole Trade Name: Albenza Indication: hydatid disease (cystic echinococcosis due to E....

General Principles of Software Validation.
April 17, 2002... Final Guidance for Industry & FDA Staff Document issued on: January 11, 2002 This document supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997. U.S. DHHS Food & Drug...