The FDA delays final rule related to off-label use; Amgen's Repatha reduces risk of death by 20%, study finds; FDA rejects AstraZeneca's hyperkalaemia drug
In short, he'll be further along the learning curve than anyone ever tapped for the nation's number-one public health regulatory slot.
In short, the Trump team, I predict, will seek to tweak FDA.
The regulator is providing examples of appropriate off-label communications.
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The previous deadline was January 9.
The bill includes two provisions that would address drugmakers' calls for clarity on sharing off-label information with payers and regulators.
Insurers and pharmacy benefit managers already have a sophisticated understanding of clinical data, the industry argued.
The FDA asked questions about the risks and benefits of allowing off-label communications.
Spurred by recent lawsuits, the FDA is scheduled to hold a two-day hearing this week on whether to allow drugmakers more latitude in promoting therapies off-label.
The agency's ambitions were fueled in part by external criticism. The barbs that stung most sharply were ones suggesting a certain indifference on the FDA's part.
The FDA will hold a public hearing in November to gather input on how it should regulate certain off-label communications.
PhRMA and BIO, which represent life sciences firms, developed principles about sharing truthful and non-misleading information with payers and providers.
FDA Commissioner Robert Califf has two plans for what he wants to achieve during his tenure. One is long-term. The other ends in early 2017.
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That change is coming about in the wake of a string of First Amendment-based losses for the FDA in federal courts around the country.
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It is worth noting that the FDA sent only nine warning letters last year, all focused on well-recognized violations, such as minimization of risk information and unsubstantiated claims.
The FDA withdrew a 2014 warning letter related to Pacira Pharmaceuticals' marketing of its painkiller Exparel as part of a settlement reached by both parties this week.
The drugmaker had sued the FDA in September over marketing restrictions for its painkiller, Exparel.
Amarin begins legally promoting off-label uses of its prescription fish-oil drug, while Pacira sues the FDA over the label for its pain drug, Exparel.
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State attorneys general accused the drugmaker of violating state consumer protection laws.
But don't expect the floodgates to open. Marketers still have to take a legal route to promote such information.
The decision, a setback for the FDA, allows the drugmaker to move forward with plans to legally promote some off-label information.
Pharma's efforts to evolve restrictions about off-label marketing move forward.
The legislation would allow drugmakers to share information about their products beyond what is included on the FDA-approved label.
The Medical Information Working Group and the Washington Legal Foundation filed briefs in support of Amarin.
An FDA letter says there was no need to go to court but experts tell MM&M this lawsuit highlights an issue that is bigger than a single pill.
The legislation would allow drugmakers to share economic information with payers beyond what is included on the FDA-approved label.
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