The new rules are expected to do away with the haphazard nature of facility inspections.
FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic communications environment.
The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.
Recent FDA guidelines for health-tracking apps mean Apple's HealthKit, and similar apps, won't have to jump regulatory hurdles before going live.
The UK's National Institute for Health and Care Excellence says it bounced Bayer's drug for failing to compare itself to current treatments, and Sanofi's over cost.
Plans for a "new regulatory supergroup" are reported to have been in the works for some time.
Italy's regulator says the companies conspired to suppress Avastin sales so Lucentis could gain market share.
The UK watchdog wants to know what's behind the rare-disease drug's high price.
The regulator—which oversees an array of matters that include deceptive advertising and robocalls—is being nudged into this part of the medical field because of the technology involved.
Critics say the FDA is not doing enough to ensure generics quality and that communications between industry and the regulator need to improve.
Industry associations want to see how money for review applications is spent.
The FDA commissioner said the agency is doing its job, not picking a fight, when it inspects drug-making facilities, and that India must take an active role for a harmonious supply chain.
The price watchdog said Sanofi's oral MS drug Aubagio is a go. The decision follows a September directive to prove the drug's cost-effectiveness.
An FDA committee is poised to review a new Primatene Mist in February.
The European Medicines Agency makes its equivalent of FDA manufacturing warning letters public.
The FDA wants more data for the proposed canagliflozin-metformin medication mix.
The regulator tells farmers to limit antibiotic use.
The FDA's Center for Drug Evaluation and Research released a preliminary year-in-review report that says the agency has cleared 26 new molecular entities this year.
Danish police are investigating the drugmaker over its decision to wait two days before announcing the FDA's February rejection.
The government division is scrutinizing marketing information for three drugs.
Reports of a Dec. 5 deal between the US and China could deepen inspectors' reach.
The leukemia drug is staying on the market, but for a more restricted patient population.
Critics worry the talked-about approval plan could mean adverse events surface far too late.
The agency's bad-ad warning letter calls the new violations "particularly troubling."
The drugmaker's green light was paired with the EMA's decision that several thousand unreported AEs were no big deal.
EyeonFDA finds that, when it comes to black-boxed drugs' marketing materials, the FDA is more likely to issue Warning Letters than untitled letters.
The regulator says the drugmaker needs to do more testing.
The drugmaker's latest financial plans could power it through mid-2015.
The company announced the layoffs Friday.
The proposed change would allow generics makers to update labels even if branded drugmakers do not, possibly opening up generics to new liability issues.
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