Food and Drug Administration News

Date Posted
Article Title
3/25/2005
Monthly Drug for Osteoporosis Approved

For postmenopausal women

3/24/2005
FDA Seeks Weaker Ethics Rules for Medical Trials, Critics Claim

But an agency official denies the accusation

3/24/2005
Device Treats Chest Aneurisms

Prevents rupture of aortic weak spot

3/21/2005
Consumer Confusion Persists on Painkillers' Safety

Some patients quit cox-2 therapy; others have cut back as questions remain

3/17/2005
Brain Cancer Drug Gets Wider Approval

With radiation, Temodar can extend patients' lives, FDA says

3/17/2005
Innovative Diabetes Drug Wins Approval

First Type 1 treatment since insulin

3/16/2005
Journal Commentary Labels FDA 'Timid and Toothless'

New England Journal of Medicine article claims agency too tied to industry

3/10/2005
Consumer Drug Ads Facing Their Moment of Truth

Less show, more show-and-tell seen in wake of drug safety hearings

2/28/2005
Hepatitis C Regimen Approved for HIV Patients

300,000 Americans infected with both

2/24/2005
Ibuprofen Controversy Continues After Pain Drug Hearings

Group says some children suffer rare, deadly syndrome after taking it

2/23/2005
New Treatment for Heart Failure

Blood pressure drug assumes dual role

2/19/2005
Health Experts Wary After FDA Panel's Cox-2 Recommendations

The painkillers' problems haven't gone away, they say

2/19/2005
Painkillers Should All Stay on Market, Despite Heart Risks: FDA Panel

Advisers vote to recommend keeping Celebrex, Vioxx and Bextra available while finding all raise cardiovascular risks

2/18/2005
2/18/2005
Patients Urge FDA Panel Not to Ban Painkillers

Hearing gets personal tales of pain relief with cox-2s

2/17/2005
FDA Whistleblower Warns of Cox-2 Risks

Vioxx increases heart dangers dramatically, Graham tells government advisers

2/16/2005
Cox-2 Drugs Take Center Stage at Government Hearings

First of three days of testimony gets underway

2/15/2005
Studies Spell Bad News for Cox-2 Drugs

Results will be focus of three days of government hearings

2/14/2005
Cox-2 Drugs Boost Blood Pressure: Study

Other research finds more evidence of heart attack, stroke risk

2/14/2005
FDA to Weigh Fate of Bextra, Celebrex, Similar Drugs

Panel must balance health risks against benefits

1/24/2005
Study Blames Vioxx for Up to 140,000 Cases of Heart Disease

As many as 40 percent of cases may have been fatal, FDA scientist contends

1/14/2005
FDA Panel Nixes Over-The-Counter Sale of Cholesterol Drug

Advisers cite need for medical supervision when taking statins

1/13/2005
1/12/2005
Report Calls for Tougher Oversight of Alternative Medicine

It also suggests stricter regulation of dietary supplements

12/24/2004
FDA Orders Broad Spectrum Review of Painkiller Drugs

Agency says it will look at studies of COX-2 and COX-1 inhibitors

12/17/2004
U.S. Halts Use of Celebrex in Cancer Trial

Will review heart safety of all cox-2 inhibitors

12/16/2004
Drug Treats Painful Side Effect of Chemotherapy

Thwarts debilitating mouth sores

12/16/2004
Spray Approved for Nasal Polyps

Treats benign growths that obstruct breathing

12/16/2004
Longer-Term Sleeping Pill Approved

Shows few signs of addictive side effects

12/13/2004
Equetro OK'd for Bipolar Disorder

Patient trials showed little blood glucose change

12/7/2004
U.S. Imports 1.2 Million More Flu Shots

German-made vaccine procured under investigational drug application

12/6/2004
U.S. Moves to Further Protect Food Supply

Effort is last of four measures to head off bioterror threat

12/3/2004
New Treatment for Overactive Bladder

Condition affects up to 20 million Americans

12/1/2004
'PillCam' Allows Doctors to Inspect Esophagus

May thwart pre-cancerous condition

11/24/2004
Safety of Entire Family of Painkillers Questioned

Experts still see a key role for cox-2 inhibitors

11/23/2004
FDA Tightens Restrictions on Accutane

Approves registry to protect women of childbearing age

11/22/2004
Electronic Device Tracks Surgical Cases

Ensures operation is done on correct patient

11/19/2004
How Safe Are the 5 Drugs?

FDA, pharmaceuticals defend process after insider names questionable medications

11/19/2004
New Drug for Advanced Lung Cancer

Extended life for some in trials

11/18/2004
FDA, Drug Industry Under Fire on Safety

Officials rebut charges they dragged feet on dangerous medications

11/16/2004
FDA: Science, Not Politics, Behind RU-486 Warning

Agency denies pressure to put tough label on abortion pill

11/15/2004
Prescription Drugs to Get Electronic IDs

FDA, pharmaceutical measure aims to curtail counterfeiting

11/5/2004
Colon Cancer Drug Wins Additional Approval

OK to combine with chemo after tumor removal

10/29/2004
Help for Dialysis Patients

New drug helps manage phosphorus levels

10/27/2004
Artificial Spinal Disc Approved

To help ease lower back pain

10/22/2004
Ultrasound Device Zaps Uterine Tumors

Not intended for childbearing women

10/18/2004
Partial Artificial Heart Approved

For patients awaiting transplant

10/15/2004
Tough Warnings Ordered for All Antidepressants

FDA says 'black-box' warning on labels is response to youth suicide potential

10/13/2004
Despite U.S. Ban, Drug Import Programs Proliferate

Federal officials weigh options as states, cities move to help residents save money

10/11/2004
FDA Denies Knowing Extent of Flu Vaccine Production Problems

Top official says agency didn't realize British plant would be shut