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Latest From Allergan, Inc.

US FDA Urged To Improve Messaging To Professional Societies On Accelerated Approval Withdrawals

Lengthy withdrawal process creates an opening for the FDA to better convey its concerns about a medicine’s benefit-risk profile in a way that impacts prescribing guidelines, Johns Hopkins’ Joshua Sharfstein says; CDER’s Jacqueline Corrigan-Curay says new expedited withdrawal procedures under omnibus law appear more ‘streamlined’ than those followed for Makena.

Review Pathway Post Market Regulation & Studies

Medicare Wastage Rebate Exceptions For Small Volume Products, Cell/Gene Therapy Urged

Packaging for such products reflects ‘unique circumstances’ that should exempt them from the rebates on discarded drugs otherwise required by the policy, stakeholders tell CMS at a ‘town hall’ forum.

Reimbursement Pricing Debate

Cipla's Advair Generic Debut In Sight, More Platform Deals On Radar Post Ethris

Cipla believes it is “pretty close” to approval for its Advair generic in the US, while another product, generic Abraxane, stands delayed currently. Following the deal with Ethris, which is progressing inhaled mRNA-based therapies, the company signals interest in platforms such as CAR-T as well.

Commercial Generic Drugs

Inside US FDA’s Return To In-Person Meetings

In an interview, OND Deputy Director of Operations Kevin Bugin describes how FDA might be able to "accelerate" the transition back to in-person meetings if the initial phase with Type A and BPD Type 1 meetings goes well. But there is still no plan to return to in-person advisory committees.

Advisory Committees Coronavirus COVID-19
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