Category Archives: Supply Chain

Court Ruling Threatens Drug Shortage Remedy

The Food and  Drug Administration may no longer be able to alleviate shortages in vital drugs by permitting the import of unapproved medicines following a decision by the Court of Appeals for the District of Columbia. The ruling of July 23, 2013 also raises broader questions about when and how FDA can “exercise regulatory discretion” […]
Also posted in Anti-counterfeiting, FDA, Safety | Tagged , , , , , , | 1 Comment

IOM: Curb Fake Meds through Track-and-Trace, but Forget "Counterfeits"

A new report from the Institute of Medicine (IOM) has drawn a lot of attention to the public health dangers of falsified and substandard medicines around the world. The aim is to build support for a range of activities that can limit the spread of fake medicines in the U.S. and help developing nations strengthen […]
Also posted in Anti-counterfeiting, compliance, Events, FDA, Manufacturing, R&D, Regulatory, Safety, Strategy | Tagged , , , , , | Leave a comment

Pharma: Get Ready for the New Supply Chains

New pharma supply chains, where chill control and traceability challenges will be far more critical, will emerge over the next decade, So it’s time, argues Julian Mosquera, for the industry to upgrade its capabilities. The pharmaceuticals industry is undergoing major disruption and every comparative benchmark indicates that the sector needs to make a step change […]
Also posted in Global, Guest Blog, Safety | Tagged , , | 1 Comment

A Simple Plan (to Save US Pharma Manufacturing)

Fernando Muzzio and Mauricio Futran propose a plan to turn around pharmaceutical manufacturing in the US. Pharmaceutical manufacturing in the US is in rapid decline. Higher regulatory standards for efficacy and safety, among other reasons, have led to a significant level of difficulty in replacing “blockbusters” developed in the 1980s and 1990s that are now […]
Also posted in Guest Blog, Technology | Tagged | 4 Comments

CDER Addresses 'Challenges of Globalization' With a New Office

In recognition of the difficulties presented by a rapidly expanding global drug market, FDA’s Center for Drug Evaluation and Research (CDER) has created a new office “dedicated to addressing the challenges of globalization and an increasingly complex drug supply chain,” according to memo sent by CDER director Janet Woodcock. The new “Office of Drug Security, […]
Also posted in FDA, Global, Regulatory, Safety | Tagged , , | Leave a comment
  • Categories

  • Meta