Month: January 2014

This joint pilot of the FDA’s Center for Devices and Radiological Health (CDRH) and Office of Regulatory Affairs (ORA) is part of FDA’s ongoing effort to apply innovative strategies that promote medical device quality.  VCIP differs from the FDA’s traditional oversight model by allowing firms to voluntarily self-identify and correct possible regulatory violations instead of undergoing FDA inspection. Types of problems identified by these manufacturers may include quality system violations and other problems, such as failure to satisfy device clearance or approval requirements or adverse event reporting requirements.  Firms with violations that raise imminent public health concerns – such as a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death – may not participate in the program.

The US Food and Drug Administration (FDA) has published a new draft guidance on the studies needed to support an abbreviated new drug application (ANDA), more commonly known as generic drug applications.

GlobalData analysts anticipate that new cholesterol treatment guidelines will be “hard to swallow” for manufacturers of other lipid-lowering drug classes, such as Merck’s & Co.’s Zetia and AbbVie’s Trilipix as the new recommendations all but discredit the usefulness of these products.  Despite this, GlobalData analysts say that the updated guidelines for treating hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) could give the statin market a substantial boost in the coming years.

 US Food and Drug Administration (FDA) officials quietly announced late on a Friday in November that their biologics online submission system had been “compromised” by an unauthorized user—hacked, in common parlance—leading to the access of users’ account information, e-mail addresses and passwords.

The World Health Organization and Health Care Without Harm, an international coalition of 473 entities in 50 countries, are calling for a global phase-out of mercury-containing fever thermometers and blood pressure cuffs by the end of this decade.