Category Archives: Manufacturing

FDA, AdvaMed Seeking Clarity on Med Device Pre-Market Approvals

By Guest Blogger | Published: September 5, 2012
by Elizabeth Hollis The FDA and the Advanced Medical Technology Association (AdvaMed) gave cardiovascular device manufacturers plenty to think about over the holiday weekend with information presented at an Aug. 28 workshop. The two bodies came together to explain requirements for 30-day notices and annual change reports for Pre-Market Approvals (PMAs), an important gateway to [...]
Also posted in FDA, Guest Blog, IP, Legal, Market Access, Meetings, Regulatory, Safety, Strategy, Technology | Tagged , | 1 Comment

Will WHO Member States Pony Up for Neglected Diseases?

By Ben Comer | Published: May 21, 2012
Recognizing that traditional market forces – namely incentives related to intellectual property and a steady demand for products – have failed in developing countries, the World Health Organization (WHO) asked a member state-nominated group to come up with ways to fund R&D and pay for the treatment of neglected diseases in the world’s poorest nations. [...]
Also posted in Emerging Markets, Global, IP, Legal, Market Access, R&D, leadership, pricing | Tagged , , , , , , , , , , | Leave a comment

Is the US Facing a Pharma Manufacturing Gap?

By Guest Blogger | Published: February 7, 2012
By Patricia Van Arnum, Pharmaceutical Technology. Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to outline the agency’s case for supporting the fifth authorization of the Prescription Drug User Fee Act (PDUFA), also known as PDUFA V. In addition to offering her support for PDUFA [...]
Also posted in Guest Blog, Regulatory | Tagged , , , | Leave a comment

Tiered Pricing Not Always a Win-Win

By Ben Comer | Published: November 22, 2011
Tiered pricing, or selling critical medicines to developing countries at a standardized discount price, can improve access in the short term, but arbitrary demographic groupings and misaligned incentives often stack the deck in favor of manufacturers, not patients.
Also posted in Corporate Responsibility, Emerging Markets, Global, IP, Market Access, R&D, Strategy, pricing | 2 Comments

New Year Night Stalkers: What Will Keep the C-Suiters Awake in 2011

By William Looney | Published: January 5, 2011
New Year Night Stalkers Eight Strategic Issues that Should Keep “C Suiters” Reaching for the NoDoz in 2011 The consensus is that 2011 will be a bad year for big pharma.  It must confront a breaking wave of patent expirations, while fiscal retrenchment has created an innovation cycle in reverse as payers find new ways to curb [...]
Also posted in Marketing, R&D, Regulatory, Strategy, Technology, compliance | Tagged , , | 5 Comments