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Regulatory & Safety: Top Headlines

FDA needs to conduct all generic manufacturing inspections requested by reviewers, report says

07-May-2015 - Although the US FDA has drastically increased its preapproval inspections of generic drug makers worldwide, the agency failed to conduct all of the inspections requested by its own generic application reviewers, according to a report from the HHS Office of the Inspector General (OIG).

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PEOPLE ON THE MOVE

Favourite for Novo Nordisk CEO suddenly quits

30-Apr-2015 - Kaare Schultz, Novo Nordisk Chief Operating Officer and planned successor as Chief Executive, resigned unexpectedly today. Plus FDA's ex-top scientist heads up US Pharmacopoeia.

FDA’s Woodcock calls to cut clinical costs via new efficiencies

30-Apr-2015 - As the cost of clinical trials continues to grow, Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA told Senators earlier this week that there are “ways to greatly improve clinical trial efficiency,” and cut costs through the use of master protocols and real-world data.

EBG BIOSIMILARS 2015

Regulators: skip clinical data and extrapolate biosimilar indications

29-Apr-2015 - Extra clinical studies are often not needed to license biosimilars for all the same indications as an originator biologic, the EMA and FDA agree.

MHLW says PIC/S membership means high quality drugs will get to patients faster

29-Apr-2015 - Japan’s membership of the PIC/S international inspection and manufacturing scheme bodes well for patients in Japan and elsewhere according to the MHLW.

WHO: Pharmas should give cash not drugs to aid Nepal earthquake relief efforts

28-Apr-2015 - Drug companies that want to support aid efforts in Nepal should donate cash rather than medicines according to the World Health Organisation (WHO).

Allergan and Hospira recalls

28-Apr-2015 - Hospira has recalled one lot of the anaesthetic Bupivacaine after a customer discovered orange and black particles floating and embedded in a glass vial.

News from CPhI Japan

Sakigake: New Japanese drug laws will foster global innovation says MHLW

28-Apr-2015 - ‘Epoch making’ revisions to Japanese drug laws have provided a pathway for development of safer, more innovative drugs according to MHLW director, Haruo Akagawa.

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