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"
Organization including the Pew Charitable Trusts are voicing basic suppor for FDA's efforts to develop an alternative approval pathway for certain drugs
People in the industry must be worried about the type of care doctors are now giving
FDA commissioner Margaret Hamburg is urging the pharmaceutical industry to improve manufacturing quality
The idea of scaling back premarket clinical trials comes under fire
While we all like the sun, life under the final rules for the "Sunshine Act" provisions of the Affordable Care Act is going to be complicated and treacherous for drug companies and their agencies.
FDA is exploring an alternative drug-approval pathway for drugs intended to address unmet medical needs by "limited use" approvals.
The Alabama Supreme Court ruled that a man who claims he was injured by a generic version of Pfizer's Reglan can sue the innovator company.
FDA has never won a First Amendment case, and its string of losses led it to bring this one under false colors
FDA commissioner Margaret Hamburg says that if academia, industry, government scientists and regulators could come together more in pre-competitive collaboration it could get more done
FDA deputy chief counsel for litigation Eric Blumberg told a December conference that "Money is clearly not doing the job...We need to employ a 'bigger hammer,' to send people to jail."
The image of pharma as corrupt is not a problem of perception. It's one of fact.
A new report says that FDA still has significant workforce and management challenges in the scientific and medical arenas that need to be addressed
An FDA Warning Letter says that oBand Centers is making misleading claims in its promotional materials for the Lap-Band
Major provisions in the FDA Safety and Innovation Act could make the approval process more transparent
FDA's drugs center wants to revisit a proposal once entertained by PhRMA to allow the agency access to all data from failed drug development programs to research whether different approaches could have saved the products.
The FDA wants to replace Medication Guides, patient-package inserts, and other consumer medication information handed out at pharmacies with a proposed Patient Medication Information (PMIs) sheet
Neither FDA nor its HHS masters seem to know how to develop an effective regulatory scheme
A White House scientific panel has recommended that FDA expand its accelerated approval program to a broader range of drugs.
The Pharmaceutical Research and Manufacturers of America (PhRMA) has adopted "principles" to guide interactions between companies and patient organizations.
Part D is the Michael Phelps of healthcare reform—providing a roadmap toward real evolution
Used for the first time in the recent $3 billion healthcare fraud settlement with GlaxoSmithKline (GSK), a new enforcement tool has joined the federal government's list of options to rein in improper medical product promotion.
Companies who submit proprietary data to FDA have a right to ensure it isn't disclosed to competitors
FDA challenged a House report that said its regulations and enforcement actions contribute to drug shortages.
An appeals court ruling says "any payment from a patent holder to a generic patent challenger who agrees to delay entry into the market" can be taken as "evidence of an unreasonable restraint of trade."
It was once thought bizarre to foist a commitment to innovation on a regulatory agency. No longer!
A new report from the House Committee on Oversight and Government Reform blames FDA for shortages of generic injectable medications.
A Yale assistant professor and a medical student have provided evidence that FDA's review process is faster than those in other countries.
Social media is messy and the regulatory framework is equally so. Get used to it.
Legislation to speed FDA approval of breakthrough drugs is being supported by both former FDA commissioner Mark McClellan, now a Brookings Institution senior fellow, and Friends of Cancer Research chairperson Ellen Sigal.