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STAT+: Pharmalittle: We’re reading about Wegovy approved for heart risks, an ALS drug puzzle, and more

STAT

Food and Drug Administration approved a label expansion for Novo Nordisk’s obesity drug Wegovy to tout its benefits for the heart, a move that could boost demand and insurance coverage for the already highly popular treatment , STAT notes. The  And of course, do keep in touch. … The U.S.

Labelling 272
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Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog: Biosimilars

GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

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Gilead takes legal action against counterfeit HIV drug network 

pharmaphorum

According to the company, the defendants reportedly sold 85,247 bottles of medicine with counterfeit Gilead labelling to pharmacies over a two-year period, using falsified supply chain documentation to conceal their origin. This works to ensure the safety and efficacy of the drugs received by patients.

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FDA Issues Guidance on Biosimilar Labeling

Pharmaceutical Commerce

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

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FDA Issues Guidance on Biosimilar Labeling

PharmaTech

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

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Experts to come together for compliance event ‘validation ready’ global labeling systems  

pharmaphorum

exploring ‘validation ready’ global labeling systems . ? . A group of industry experts is set to explore how medical device, clinical trial and pharmaceutical companies can proactively manage labeling risk. The post Experts to come together for compliance event ‘validation ready’ global labeling systems appeared first on.

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Typical GMP documentation in a quality control laboratory

GMPSOP

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. The significance of well-designed GMP documentations is immense.