efficacy Tagged Articles
FDA stops pediatric testing of calcium-sensing receptor Sensipar
Pediatric clinical trials of the drug Sensipar (cinacalcet hydrochloride) have been halted by the Food and Drug Administration (FDA) after a 14-year-old patient died. The FDA says it has not yet confirmed whether the drug played a role in the
FDA warns medical facilities about counterfeit Botox
Batches of Botox shipped from a Canadian drug supplier to more than 350 medical facilities in the United States may be counterfeit and unsafe, the Food and Drug Administration (FDA) warned. The drugs were shipped by suppliers owned by Canada
Roche agrees to compromise with BMJ over Tamiflu safety, efficacy data
Pharmaceutical company Roche says it has agreed to talk to external groups about full access to data on its anti-flu medication Tamiflu (oseltamivir), a move prompted by criticism that the drug company had refused to release data on the safety
Appeals court says free speech applies to drug company reps, too
Pharmaceuticals are cleared by the Food and Drug Administration (FDA) for specific uses only after studies have shown that the drug is both safe and effective for the conditions for which it is approved. Doctors have the discretion to prescribe
50th anniversary for Kefauver-Harris Amendment to ensure safer, more effective drugs
This year marks the 50th anniversary of the Kefauver-Harris Amendment, action that required drug companies provide more thorough data on the safety and efficacy of prescription drugs before they are approved. The amendment led to the development of evidence-based drug
FDA approves first flu shot using animal cell technology
The first seasonal flu vaccine using animal cell technology instead of the 50-year-old egg method has been approved by the Food and Drug Administration (FDA). The new flu shot, Flucelvax, is made by Novartis and is approved for people 18
Novel new type 2 diabetes treatment shows promise in clinical trials
A novel new type 2 diabetes drug is showing good safety and efficacy in clinical trials, drug maker Poxel announced this week.
FDA to decide fate of blood thinner Eliquis by March
The Food and Drug Administration (FDA) says it will decide by March 17, 2013, whether to approve Bristol-Myers Squibb Co and Pfizer Inc.’s blood thinner Eliquis for the prevention of strokes in patients with atrial fibrillation. Drug regulators rejected Eliquis
Authors say FDA approved Pradaxa before safety was established
An effort by the Food and Drug Administration (FDA) to expedite the approval of new drugs for serious medical conditions has allowed some medications to be cleared with inadequate testing to determine safety and efficacy, two drug safety experts claim
