Passing the 21st Century Cures Act was a bipartisan success due to open lines of dialogue among stakeholders
Perhaps the best testament to Commissioner Hamburg's tenure is that crises were uniformly handled responsibly
After a decade spent stalling, denying and attacking critics, the University of Minnesota has finally admitted some complicity in the death of a patient during a clinical drug trial.
The FDA has to respect First Amendment limitations regulating scientific communication
The FDA must address its policies to accommodate the new medical and media environment
With POC on the march, the FDA will have to stretch its monitoring efforts to keep up
One issue lurking for marketers is the potential elimination of the tax exemption for advertising
I come not to bury government but to praise it—at least the singular agency I know best: FDA
Demonizing new treatments distracts from the real problem: policies that focus on the near-term
A charge of sexism against the FDA clouds the views surrounding a drug's application
Problems and changes have set ablaze criticism over the Sunshine Act's implementation
What happens when it's the FDA—not a medical marketer—that is doing the overstating?
A patient who is diagnosed earlier and receives the most efficacious treatment is the least expensive
A Manhattan Institute analysis says that helping underperforming FDA drug review divisions match the output of high-performing divisions could cut development costs and speed approval of new treatments.
Nineteen Republicans on the House Energy and Commerce Committee want FDA commissioner Margaret Hamburg to explain the role the American Association for Justice (trial lawyers) played in drafting proposed changes to generic drug labeling.
FDA has insisted that its antique regulations can address every new promotional challenge
Former Speaker of the House and presidential candidate Newt Gingrich has declared that it's time to replace FDA
The more clarity that FDA provides, the more confident companies can be in their medical communications
US senators Joe Manchin (D-WV) and David Vitter (R-LA) are asking whether a "pay-to-play" meeting between drug industry executives and FDA officials influenced the agency's approval of Zohydro
FDA's Office of Prescription Drug Promotion (OPDP) plans to research the effects that could follow changing the risk information the agency requires to be included in such direct-to-consumer ads.
We need for pharmaceutical companies to come forward and make the pledge to stop hiding data
California Democrat Henry Waxman, one of the strongest FDA overseers and drug industry critics on Capitol Hill, will step down when the House of Representatives adjourns for the mid-term elections
FDA's drug center says it has been so overwhelmed with industry's response to its new Breakthrough Therapy program that it is becoming difficult to promise an "all hands" commitment.
FDA's Warning Letter to Aegerion is a bureaucratic thumb in the eye to the US Court of Appeals
The US Supreme Court has declined, without comment, to hear a closely watched appeal by former InterMune CEO Scott Harkonen on whether someone can be prosecuted for speaking truthfully about a drug.
Public Citizen has written FDA asking it to stop making "misleading" statements about pharmacy compounding
It's fast becoming an n of 1 world, where every disease is an orphan disease and success is measured by individual outcomes
A McKinsey Center for Government analysis shows that in the period 2001-2010, FDA approved 88% of NDAs and BLAs that were supported by advisory committees and did not approve 86% of those not endorsed by the committees.
Under a $4-million contract from FDA, RTI International researchers will look at consumers' responses to risk, benefit and cost information in direct-to-consumer prescription drug ads
Keeping up with quality programs often feels like a safari in a jungle of government paperwork
Under pressure from Public Citizen and FDA, Dermatologic and Ophthalmic Drugs Advisory Committee chair Lynn Drake withdrew her acceptance of an invitation to provide a presentation to industry on winning a favorable panel endorsement.
Two researchers say that expedited review of new drugs may have exposed some patients to safety risks that had not been well characterized.
Could PAG change the FDA inspection paradigm from honest, objective assessments to faster, easier ones?
The Federal Trade Commission has announced a Dec. 4 workshop to "examine the practice of blending advertisements with news, entertainment, and other content in digital media."
FDA's director of drugs, Janet Woodcock, said in September that she will personally direct the agency's latest push to advance pharmaceutical quality.
By opposing making clinical trial data public, Pharma is once again swimming against the current
FDA stakeholders in industry and academia told the agency in August that they're concerned about its newest initiative to make clinical trial data more publicly available
A study of government drug review advisory panels suggests that those with members who have financial ties to the drug industry recommended expansion of labeled disease indications for the drugs examined
CMS recognized that the rules in place for CME provide for separation from supporter influence
The Federal Trade Commission (FTC) says that a June Supreme Court decision finding so-called pay-for-delay patent dispute settlements not inherently anticompetitive has put the agency in a stronger position to protect consumers from such settlements
A study of prescription drug direct-to-consumer advertising suggests that it may promote over-diagnosis of high cholesterol and over-treatment for populations where risks of statin use may outweigh potential benefits.
Just like the NSA can monitor national security, FDA market-watchers can track what pharma marketers are doing.
The FDA is reviewing two drug-promotion guidances, according to CDER Office of Drug Promotion director Tom Abrams
The Second Circuit Court of Appeals affirmed a New York federal court ruling that scientific opinions in a journal article could not give rise to claims of false advertising
While there are successes in the battle for better adherence/compliance, we're losing the war
FDA director of drug evaluation and research Janet Woodcock says she is amazed that FDA has had more than 30 requests for its new breakthrough therapy designations and it has granted 11 already.
Appendages of the HHS secretary's apron strings, FDA commissioners must toe the "party line"
FDA drug safety officials say that an influx of numerous bleeding reports associated with Boehringer Ingelheim's blood thinner Pradaxa (dabigatran) is a case of "stimulated reporting"
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