Tag Archives: Supply Chain

Supplier Audit Program Marks Progress

The Rx360 pharmaceutical supply chain consortium celebrated its first five years with an anniversary conference on June 5  in Washington, D.C., featuring key FDA officials and industry leaders. This collaborative effort to streamline and coordinate manufacturer audits of ingredient suppliers was launched in 2009 in response to the heparin adulteration crisis, which raised broad concerns […]
Posted in FDA, Regulatory, Supply Chain | Also tagged , , | Leave a comment

China Supply Chain Progress Still Hampered by Corruption, Pollution, Working Conditions

Supply chains risks in China still include extremely high levels of corruption, environmental pollution issues and slow working conditions reforms, according to new analysis from Sedex.
Posted in Emerging Markets, Global, Supply Chain | Also tagged , , | Leave a comment

Track-and-Trace Not Enough to Halt Drug Counterfeiters

Despite recent legislation to establish a more secure pharmaceutical supply chain to deliver high quality, approved medicines to American patients, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight. Criminals are expanding from “lifestyle” drugs to widely used anti-cholesterol and cancer medicines, attracted by huge profits and low risks […]
Posted in FDA, Regulatory, Safety, Supply Chain | Also tagged , , , , | Leave a comment

Drug Shortages Continue to Plague Health Care System

Despite notable successes in preventing and mitigating short supplies of important medicines, the drug shortage crisis still disrupts medical treatment and gives drug manufacturers a bad name. The Food and Drug Administration is doing a better job of identifying potential shortage situations and implementing relief strategies, but many supply problems continue to limit treatment options […]
Posted in FDA, Legal, Manufacturing, Safety, Supply Chain | Also tagged , , , , , | Leave a comment

Senate Finalizes Drug Compounding, Tracking Legislation

Congress gave final approval this week to new legislation to strengthen Food and Drug Administration authority to oversee large pharmacy compounders of sterile injectibles and to require more comprehensive tracking of prescription drugs moving through the global supply chain. The House passed the the Drug Quality and Security Act in late September, but Senate action […]
Posted in FDA, Global, Regulatory, Safety | Also tagged , , , , , , , , | Leave a comment
  • Categories

  • Meta