In a surprising development that has revived intense speculation over the fate of Amarin, the FDA has delayed any decision about whether to widen an indication for the Vascepa prescription fish oil pill. The move was expected in December 2013 and the delay has now triggered intrigue over what appears to be a complex minuet between the agency and the ‘little drugmaker that could.’
The FDA announced in December 2013 that it is recommending the bedtime dose of Zolpidem (brand name Ambien) be lowered due to the risk of next-morning impairment. In a press release issued in December 2013, the FDA says it recommending the change “because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.” The FDA is requiring manufacturers of Ambien, Ambien CR, Edluar and Zolpimist to lower the recommended dose “because use of lower doses of Zolpidem will result in lower blood levels in the morning.”
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans revisions to its Investigational Device Exemption process to improve clinical trial management for manufacturers and sponsors, and may also consider down-classifying some devices from Class III Premarket Approval registration requirements.
A wide variety of medical device stakeholders gave the Food and Drug Administration suggestions on how to improve the draft guidance for implementing the Global Unique Device Identification Database (GUDID).
Consultants for Booz Allen Hamilton recommend that the FDA implement more training, metrics and quality management to improve the consistency and transparency of the medtech review process.
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.