Generics Bulletin is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Regulation

Set Alert for Regulation

Shilpa Hit With FDA Warning Letter

India’s Shilpa Medicare has received a warning letter from the US FDA for its finished dosage formulation facility in Jadcherla, Telangana. The company has insisted that supplies from the facility will not be disrupted while it engages with the FDA to resolve the issues.

FDA Manufacturing

Mylan Obtains CHMP Backing For Revlimid Generic In Two Indications

Mylan is taking aim at a lucrative oral solid formulation in Europe, with the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending approval for the company’s generic version of Revlimid (lenalidomide) capsules.

Generic Drugs Regulation

Podcast: The UK's New Biosimilars Licensing Pathway

In this podcast discussion, Generics Bulletin editor David Wallace talks to Duncan Emerton, director of Custom Intelligence and Analytics for Informa Pharma Intelligence, about the UK's new licensing procedure for biosimilars.

Biosimilars Regulation

Australia Changes Patent Notification Requirements

Australia’s Therapeutic Goods Administration has set out proposals for a change to early-notification requirements for generic and biosimilar sponsors.

Regulation Intellectual Property

AAM Urges FDA To Reassess Nitrosamines

The AAM has published a position paper on nitrosamines that urges the FDA to revisit and reassess its safety limits for nitrosamines in pharmaceuticals, while also proposing a “science-driven” risk-based approach to evaluate drugs for the potential presence of nitrosamines.

Generic Drugs Regulation

Industry Urges Medicare Rethink On 505(b)(2) Policy

Teva, Sun and the AAM are among those urging the CMS to rescind its proposal to reimburse Part B drugs approved under section 505(b)(2) as multiple source products. The proposal would target one relatively small but growing part of Medicare Rx spending and reflects CMS’ ongoing concern with fast rising costs in the program.

Value-Added Medicines Reimbursement
See All
UsernamePublicRestriction

Register