Tag:
Janet Woodcock
Latest Headlines
Latest Headlines
Support seen for U.S. plan to speed nods for 'breakthrough' drugs
This year the agency and U.S. lawmakers appear to be supportive of a plan that would help pharma groups race to the market with breakthrough drugs.
Regulators start thinking creatively about new approval pathway
FDA officials have won close attention for some creative thinking under way at the agency about a potential new approval pathway for a particular type of therapy. Dr. Janet Woodcock told reporters...
Woodcock: More predictable manufacturing may ease regulations
Drug manufacturing experts from the 1950s would have no trouble recognizing today's manufacturing processes, according to the FDA's Janet Woodcock. But that will change as batch processing gives way
FDA's Woodcock: What to expect in the next 25 years of medicine
How has the biopharma industry evolved over the last 25 years, and what can we expect from the industry in the next two and a half decades? Those were questions CDER director Janet Woodcock set out
PDUFA committee hearing draws a crowd
FDA's Janet Woodcock faced some hostile House Republicans yesterday at a packed committee hearing, during which she testified about reauthorization of the Prescription Drug User Fee Act. Report
Woodcock: FDA may tighten generic-drug rules
FDA may act on anecdotal evidence that some generic drugs don't work as well as their branded counterparts. The agency's CDER chief Janet Woodcock told generics industry folks at a conference that
FDA's Woodcock draws conflicts-of-interest probe
The FDA's drugs chief has found herself in the crosshairs of a conflict-of-interest probe. The Wall Street Journal reports today that the HHS inspector general is investigating allegations from
Survey says: Nissen or Rost for FDA Commish
Steven Nissen ( photo ) may be on Big Pharma's short list for the least desirable candidate for FDA Commissioner, but many apparently think its critics like him who should be at the top of the list.
Sweep the FDA clean, Stupak says
Rep. Bart Stupak, the influential Michigan Democrat known so well to pharma, is lobbying President-elect Barack Obama for a wholesale change in FDA leadership. A frequent critic of the agency, Stupak
Who will take over at the FDA, HHS?
With a new presidential administration, of course, comes new agency leadership... and talk is already flying about appointees to your favorite health overseers, the Department of Health and Human
