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The Center for Biologics Evaluation and Research (CBER) has released details about how it will respond to reports of counterfeit drugs and what it will expect from drug manufacturers.
Four House lawmakers sent letters last week to White House Chief of Staff Andrew Card and Office of Management and Budget (OMB) Director Joshua Bolten demanding additional information about the discrepancy between Medicare cost estimates from the Centers for Medicare & Medicaid Services (CMS) and the Congressional Budget Office (CBO).
The FDA last week mandated sweeping content and warning labeling changes for all orally ingested OTC drug products containing calcium, magnesium and potassium as active or inactive ingredients.
The FDA has given generic firms Endo Pharmaceuticals and Teva Pharmaceutical approval to market versions of Purdue Pharma’s powerful pain treatment OxyContin (oxycodone HCl), but ongoing patent litigation has put a hold on the product launches.
Mark McClellan, former commissioner of the FDA, is officially the new administrator of the Centers for Medicare & Medicaid Services (CMS). McClellan was sworn in last week and began work Friday, according to an HHS spokesperson.
The FDA has told Corixa to stop distributing a promotional video for its combination cancer treatment and provide the agency’s Division of Drug Marketing, Advertising and Communications (DDMAC) with a plan of action to correct misleading safety and efficacy claims made in the material.
The HHS Task Force on Drug Reimportation convened its first public meeting earlier this month, at which PhRMA found itself in agreement with consumer advocates on one key topic: the push to get the FDA to publish a final rule on paper pedigrees.
Antidepressant drug manufacturers are being asked by the FDA to include warnings on product labeling recommending closer monitoring of adult and pediatric patients taking the drugs for worsening depression and suicidal thinking or behavior.
Drug manufacturers have told the FDA that the number of samples recommended by the agency for testing in-process dosage units during tablet manufacturing is too high and would likely place a burden on firms.
Lawmakers from the House Energy and Commerce Committee demanded last week the FDA release scores of agency records related to the potential suicide risk posed by antidepressant use among children and whether an agency medical officer was prevented from presenting findings at an advisory committee meeting last month.