Category Archives: Safety

Congress, FDA Should Consider Tech Solutions for Safer Compounding

By Guest Blogger | Published: March 14, 2013

By Niels Erik Hansen Last fall’s deadly meningitis outbreak linked to contaminated steroid injections is a tragic reminder of the risk of errors inherent in manual pharmacy medication compounding. Unsanitary conditions at the Massachusetts compounding pharmacy that made the injections resulted in fungal contamination of the drugs. The resulting outbreak sickened nearly 700 people in [...]

Also posted in Guest Blog, Manufacturing, Regulatory, Technology, compliance, healthcare | Tagged compounded drugs, compounding pharmacies, Congress, FDA, Pharmacy | Leave a comment

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

By Jill Wechsler | Published: February 19, 2013

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, Events, FDA, Manufacturing, R&D, Regulatory, Strategy, Supply Chain, compliance | Tagged Institute of Medicine, IOM, National Institute of Standards and Technology, NIST, Public health, Supply Chain | Leave a comment

Patients on the Picket Line

By Ben Comer | Published: February 5, 2013

Good science can’t be rushed, even when the lives of patients hang in the balance. But regulatory science, and its relationship to a drug’s commercial success or failure, can inadvertently block access to individual patients in their hour of need.

Also posted in Biotech, FDA, Legal, Market Access, Regulatory, healthcare | Tagged Abigail Alliance, breakthrough therapies, Breast cancer, Cancer, compassionate use, Expanded Access Programs, FDA, FDA safety and innovation act, HHS, Market Access, patient advocates, PDUFA V, policy | Leave a comment

Five Compliance Questions to Ask Yourself, from the DOJ

By Ben Comer | Published: January 31, 2013

At CBI’s 10th Annual Pharmaceutical Compliance Congress, Maame Ewusi-Mensah Frimpong, deputy assistant attorney general, consumer protection branch, civil division, at the US Department of Justice, said being compliant means understanding people, and their motivations. Frimpong said non-compliance boils down to a failure of individuals, and offered five questions for chief compliance officers to ask themselves [...]

Also posted in Corporate Responsibility, Legal, Regulatory, Strategy, compliance, leadership | Tagged compliance, DoJ, Maame Ewusi-Mensah Frimpong | Leave a comment

UN Pact Scuttles Anti-Vaccine Provision

By Jill Wechsler | Published: January 24, 2013

A new international agreement to reduce mercury contamination of air and water was recently adopted by 140 countries, without a proposal that threatened to limit access to vaccines in much of the world. The credit goes to public health authorities and medical experts who challenged a provision blocking production of vaccines with the preservative thimerosal, [...]

Also posted in Emerging Markets, FDA, Global, Legal, Market Access, Patient Communication, healthcare | Tagged autism, developing countries, patient advocates, patient groups, thimerosol, vaccines, WHO | 1 Comment