Medtech Insight: 世界の医療機器・医療技術の最新情報

Compliance Corner: 2 FDA Compliance Branch Heads Talk Regulatory Meetings – And What You Can Expect

23 Aug 2019

US FDA Compliance Branch directors Gina Brackett and Melissa Michurski shed light on the agency's use of regulatory meetings. The FDA has been pulling enforcement punches in recent years, relying more on holding the face-to-face meetings than sending warning letters.

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

FTC Wades Into ‘Rebate Walls’ And Biosimilar Access With Remicade Investigation

09 Aug 2019

Investigation may help define when rebate arrangements seeking to protect a brand against biosimilar competition are anticompetitive.

HBW Insight

Japan's New Rx-To-OTC Procedure Exacerbating Switch Blockage Says JSMI

07 Aug 2019

Japan's new Rx-to-OTC switch procedure has exacerbated a "switch lag" compared with developed countries, says Japan Self-Medication Industry senior adviser Toshi Tominaga in an exclusive interview with HBW Insight. Tominaga proposes improvements such as self-care education for consumers and drug usage advice included by firms in switch applications to help balance the risk-benefit decisions of expert judges.

In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース

How To Negotiate With Public Payers: Five Lessons - And A Few Cautions - From The UK's New Pact On Drug Price And Access

By William Looney 30 Jul 2019

In today’s globalized market for medicines, national rules on pricing and access are abundantly shared and more transparent than opaque. In Vivo speaks to the UK branded industry’s negotiator for the latest five-year joint pricing pact with the government, Richard Torbett, who outlines, among other topics, five widely applicable precedents from the talks that can work in “getting to yes” – despite the fractious budgetary climate for health care evident in all major country markets. 

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Canada: National Pharmacare Or 'Fill The Gaps'?

29 Jul 2019

A national pharmacare program in Canada could make it harder to access higher cost drugs.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Siemens Cybersecurity Expert Says Medtech Industry Has 'Perverse Incentive' To Not Disclose Vulnerabilities – Might A New Law Be The Fix?

26 Jul 2019

The fear of losing business by being transparent about cybersecurity vulnerabilities means there's "a perverse incentive in some parts of the market that encourages a lack of disclosure," Siemens' Harrison Wadsworth says. But the US FDA's Suzanne Schwartz believes coordinated vulnerability disclosure legislation could "level the playing field."

Cipla Docks Into China With Manufacturing Plans In Tow

By Anju Ghangurde 26 Jul 2019

More Indian companies are headed to China, with Cipla the latest to seal a joint venture there, though the firm has previous links with the country. Respiratory products will lead Cipla’s line-up in China, a market seen as a crucial cog in the firm’s future road map.

Medtech Insight: 世界の医療機器・医療技術の最新情報

One Small Step For US FDA, But Maybe A Giant Leap For SaMDs

By ferdous-al-faruque 26 Jul 2019

In a midyear update from the FDA, regulators say a retrospective review of companies in its pre-cert pilot program has concluded that evaluating a company for excellence markers could be sufficient to let Software as a Medical Device (SaMD) onto the market. However, at least one critic says the update doesn’t answer some of the most critical questions about whether the program meets the agency's own requirements and if it creates unfair advantages for certain companies.