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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Providing significant policy support to the annual update of the Orange Book Preface.

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STAT+: Pharmalittle: We’re reading about Bavarian Nordic’s mpox shot, a crackdown on Ozempic prescribing and more

STAT

Or if you prefer to enjoy the great indoors, you could curl up with a good book or binge watch moving pictures on the telly. One doctor said he thinks the company wants to discourage using the drugs for unapproved purposes, a practice called off-label prescribing, which is legal and accepted in American medicine. But be safe.

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FDA whittles back Aduhelm approval amid concern over broad label

pharmaphorum

The updated label for Aduhelm (aducanumab) says it should only be used in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia, according to an update from the drug’s developers. ” The post FDA whittles back Aduhelm approval amid concern over broad label appeared first on.

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FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “replicamab-cznm.”

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6 Digital Tools at the Center of Healthcare Digitalization [INFOGRAPHIC]

Pharma Marketing Network

Download this infographic and learn which 6 digital tools are at the center of digitalization and how the will influence the future of Pharma marketing in 2021 and beyond. Company Email *. The post 6 Digital Tools at the Center of Healthcare Digitalization [INFOGRAPHIC] appeared first on Pharma Marketing Network.

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How Label Management Solutions Can Help CDMOS Grow Their In-House Capabilities

pharmaphorum

BRINGING IT ALL HOME: HOW LABEL MANAGEMENT SOLUTIONS. In this blog, PRISYM ID’s Clinical Trials Sales Manager Bob Bowdish looks at the challenges of in-sourcing label management processes for CDMOs, and explores how they can be overcome by investing in a cloud-based, validation-ready labeling solution. Stick or twist?

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EU gives narrower label to Apellis, Sobi’s PNH drug

pharmaphorum

Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than in the US. The post EU gives narrower label to Apellis, Sobi’s PNH drug appeared first on.