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Alexion Gets A Bad Grade On An FDA Inspection

One of the darlings of the biotech industry has suffered a blow following an FDA inspection of its Rhode Island facility. Alexion Pharmaceuticals disclosed this morning that the agency issued a...

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Another Day, Another Problem For Hospira

Like The Gang That Couldn't Shoot Straight, Hospira is encountering yet another manufacturing woe. Late last week, the drugmaker recalled a lot of sodium injectables after a customer identified several...

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Pharmalot... Pharmalittle.. Good Morning

Hello, everyone, and how are you this morning? A shiny sun is hovering over the Pharmalot corporate campus where, as usual, we are scurrying about to deposit short people at school houses and officials...

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Social Media Does Not Incur FDA Wrath, After All

For the past few years, one obsession in the pharmaceutical industry is the proliferation of social media tools and the lack of regulatory guidance from the FDA on how to use them without getting into...

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Who Said Anything About Good Manufacturing Practices?

A recent warning letter issued by the FDA to Asada Milling, an active pharmaceutical ingredient supplier based in Japan, may prompt you to ask whether a drug in which you have any type of  interest...

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FDA, A Tuberculosis Drug And Surrogate Markers

Late last year, the FDA approved a first-in-class medication to treat multi-drug resistant tuberculosis. The agency did so after an advisory committee unanimously recommended accelerated approval for...

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Judge Rules Morning After Pill Restrictions Should Be Lifted

In what some are calling a landmark decision, a federal court judge has ruled that the morning after pill should be made available "without a prescription and without point-of-sale or age restrictions...

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A State Bill Over Drug Shortages Opens A Compounding Loophole

In the wake of the pharmacy compounding scandal that has led to 730 cases of fungal meningitis, including 51 deaths, across the country, pressure is being placed on both the FDA and state pharmacy...

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Waiter, There's Cardboard In My Sample: FDA Warns Pfizer Over Manufacturing...

In its latest bid to clamp down on wayward drug manufacturing, the FDA cited a Pfizer plant in Italy for violating some fairly basic procedures. The first involved problems with testing samples of...

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Another State Smacks Down Biosimilar Legislation

Yet another state has rejected legislation that would make it more difficult to allow substitutions of biosimilars. This time, Maryland has declined to endorse the concept, which was advocated by some...

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Pharmalot... Pharmalittle.. Good Morning

Hello, everyone, and how are you today? A shiny sun is hovering over the Pharmalot corporate campus, where we are busy with the usual early morning matters. As always, we are getting a fresh start with...

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What Adverse Events? Sales Reps Misinform Docs About Side Effects

There is little, if any debate that pharmaceutical sales reps are hired to sell. The operative word in the job title, after all, is ‘sales.’ But a new study raises concern that the promotional push is...

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The Obama Budget, The FDA and Prescription Drugs

Earlier this week, when tech problems conspired to derail our communication with you, the Obama administration released its budget for Fiscal Year 2014. And we feel compelled to go on the record with...

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FDA To Review Controversial Avandia Clinical Trial In June

Nearly three years after the FDA greatly restricted use of the controversial Avandia diabetes pill over increased risks of heart attacks and strokes, the agency is convening a two-day meeting in June...

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Pharmalot... Pharmalittle... Good Morning

Hello, everyone, and welcome to another working week. We hope the all-too-short weekend was invigorating, because that crushing routine of meetings and deadlines and what-not has now returned. Our own...

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FDA's Abrams: That Long-Awaited Social Media Guidance Is Coming

For the past few years, drugmakers have grappled with the Internet and how to promote their medicines to an increasingly interactive public. Although the FDA held a widely attended meeting in 2009 and...

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Troubled Compounders: What FDA Knew And When It Knew

After months of anticipation, a House committee is holding a hearing today to review a scathing report about the extent to which the FDA knew about the manufacturing issues at the New England...

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Pharmalot... Pharmalittle.. Good Morning

And so, another busy day is on the way. With the barrage of tech problems we have been experiencing - notice some stories still lack images, for instance, among many other problems  - we are reminded...

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Reader Poll: Should FDA Have Barred Generic OxyContin?

In a highly controversial move, the FDA last night announced it would not approve generic versions of the older form of the OxyContin painkiller over concerns that the drugs would be susceptible to...

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Fat Chance? FDA Loosens Reins On Vivus Diet Pill, But Is It Enough?

After considerable anticipation, the FDA has finally eased restrictions on how the Vivus diet pill can be made accessible. By amending a Risk Evaluation & Mitigation Strategy, or REMS, Qsymia can...

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