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Regulation

Set Alert for Regulation

FDA Updates ‘Purple Book’ Database

The US FDA’s ‘Purple Book’ which was created “to improve transparency and functionality for stakeholders by providing a complete view of biological product options” has been updated after being recently transitioned into an online database.

Biosimilars FDA

FDA Expedites ANDA Postapproval Manufacturing Changes

Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.

User Fees Generic Drugs

Industry Offers Mixed Response To Latest Brexit Advice

While the off-patent industry has welcomed concrete advice from the UK government over potential disruptions to medicines supplies when the country’s transition period with the EU expires on 31 December, concerns have been raised over the ability to build up safety stocks in the context of the COVID-19 pandemic, as well as a lack of clarity over the future regulatory landscape and pandemic-related procurement initiatives.

Brexit Trade

UK Recommends Against Common Drugs For Chronic Primary Pain

Paracetamol, opioids and non-steroidal anti-inflammatory drugs are among the common medicines that “can do more harm than good” and should not be used for managing chronic primary pain, according to a draft NICE guideline.

Regulation Generic Drugs

WHO Prequalifies More Biosimilars

The World Health Organization has recently added further biosimilar versions of trastuzumab to its list of prequalified products, along with Roche’s original trastuzumab and rituximab brands, Herceptin and MabThera/Rituxan.

Biosimilars Regulation

Procurement Must Look Beyond Price To Ensure Supply Chain Security

A globally co-ordinated approach to sourcing that rewards non-pricing criteria is imperative to bolster the security of the off-patent industry’s supply chain in the wake of the coronavirus pandemic, James Burt tells Generics Bulletin in the second part of our exclusive interview.

Pricing Strategies Manufacturing
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