Tag:
Margaret Hamburg
Latest Headlines
Latest Headlines
FDA, industry differ on level of track and trace needed in U.S.
Drug manufacturers may have derailed the FDA's plan to force creation of a vial-specific tracking plan to combat counterfeit drugs.
Hamburg says FDA needs more leeway to combat drug fakes
FDA Commissioner Margaret Hamburg tells CNN she's "very eager to work with Congress" on new powers and penalties for fighting counterfeit drugs.
FDA commish counters industry critics on expert conflict rules
There's been an ongoing debate in biopharma circles over the impact a shortage of drug experts is having on the FDA's panel review process. But anyone looking for the agency to welcome changes in the
Congresswoman: Novartis troubles call for more FDA oversight
California Congresswoman Mary Bono Mack said she is perplexed that FDA inspectors continued to cite problems at the Novartis ( $NVS ) Lincoln, NE, plant without holding the drugmaker accountable. The...
HHS chief smacks down FDA's Plan B decision
Look for more hot debate about HHS Secretary Kathleen Sebelius' decision to trump the FDA on expanding access to the Plan B contraceptive. People are talking not only because it's about birth
Jimenez offers bouquet to FDA's Hamburg
Novartis ( $NVS ) CEO Joe Jimenez ( photo ) is no stranger to the executive Q&A; he's been chatted up by almost every big media outlet there is. However, every once in a while, he drops a bit of new
Skyline's Freund slams FDA's tougher stance on drug programs
Some recent remarks on the new culture of innovation at the FDA by Commissioner Margaret Hamburg drew a caustic response from Skyline Ventures founder John Freund, a big investor in biotech companies
FDA weighs changes to policy on advisor conflicts
FDA may loosen its conflicts-of-interest rules governing scientists who serve on its advisory committees, Commissioner Margaret Hamburg said, in an attempt to ensure that it gets enough expert
FDA commish signals plan to loosen AdComm conflict rules
Under growing pressure from Republican lawmakers and drug manufacturers to speed up and de-risk the approval process, FDA Commissioner Margaret Hamburg has been signaling a willingness to relax the
Hamburg appoints FDA deputies; Spielberg oversees drugs
FDA Commissioner Margaret Hamburg has hired from the outside and promoted from within in naming two deputy commissioners. Stephen Spielberg becomes deputy commissioner for medical products and
