The US Food and Drug Administration (FDA) has issued a new advisory designed to help drugmakers prevent the formation of glass fragments in vials following a spate of recent recalls.
The US FDA has rejected MannKind’s inhaled insulin Afrezza and called for more clinical trials to prove the product’s “Dreamboat” delivery tech is comparable to the MedTone device used in earlier studies.
Johnson & Johnson (J&J) dominated recall and quality control (QC) news over the past year but others also faced issues. in-PharmaTechnologist presents five of our most read QC articles of 2010.
The shift towards a complex global supply chain incorporating many suppliers and service providers is driving adoption of modern analytical methods to ensure quality.
In the 20 month period before the heparin crisis no Chinese producers were inspected by the FDA and efforts during and since have been hindered by legal and practical challenges.
Overseas offices will help the FDA schedule inspections more quickly in times of crisis but, as yet, employees based abroad have visited relatively few facilities.
ACRO wants the US FDA’s overseas offices to play more of a role in monitoring clinical trials, and is calling for an additional $35m (€25.3m) to fund the work.
Overseas FDA offices have realised immediate benefits but strategic planning is needed to ensure the ventures, critical aspects of the agency’s ability to ensure drug quality, are long-term successes according to the GAO.
Revision to FDA guidance on adverse event reporting is a positive step and forms part of a welcome increased focus on safety, says the CEO of Prism Ideas.
The FDA is to collaborate with the WHO to build a global surveillance and monitoring system for combating falsified medicines and breaches of the supply chain.
Eurand says Zenpap important to Q1 growth that recent FDA move provides the drug with significant potential for further expansion in cystic fibrosis (CF) market
The USP and FDA must work to identify counterfeited or intentionally adulterated products before they enter the healthcare system by collaborating on the modification of monographs, according to Margaret Hamburg.
US Food and Drug Administration (FDA) request for more Afrezza data is not safety related and will not require new clinical trials, says developer MannKind.
The FDA has issued draft guidance detailing the information that should be submitted to an IRB as part of the continuing review of a clinical trial, with particular emphasis placed on the rise of multi-site studies.
Irish CRO Icon has received a US Food and Drug Administration (FDA) warning letter relating to two studies of an antibiotic it conducted between 2004 and 2006.
The FDA has warned consumers about the spread of counterfeit H1N1 treatments after the agency bought products advertised as Tamiflu (oseltamivir) that contained none of the active ingredient.
Caraco Pharmaceutical Laboratories has entered into a consent decree with the FDA which details a series of measures that must be fulfilled to allow the company to resume manufacturing.
The FDA is to establish current good manufacturing practice (cGMP) requirements for combination products to eliminate inconsistencies that could affect product safety and public health.
The FDA is hoping to increase the likelihood of a clinical trial being successful by making best use of science and alternative study designs and has issued end-of-Phase IIa (EOP2A) meeting guidance to explain the process.
The FDA has approved four H1N1 vaccines, made by CSL, AstraZeneca, Novartis and Sanofi-Aventis, that will be distributed in the next four weeks as part of the US’ swine flu preparation.
The FDA has issued an import alert against products manufactured at two Apotex facilities after the agency issued a warning letter, which raised several issues that the company is now working to resolve.
Following a review of the backlog of postmarketing studies the FDA has initiated changes to improve its processes, including developing Manuals of Policies and Procedures (MAPP) to track the status of trials.
The US Food and Drug Administration (FDA) has enhanced its debarment and disqualification procedures to ensure clinical trial investigators meet legal requirements.
Mylan and the FDA appear to be in disagreement about whether investigations into quality controls at a US facility are ongoing, with both releasing seemingly contradictory statements.
US Marshals have seized products from Caraco’s facilities in Michigan because of concerns over cGMP compliance, which has led to Sun Pharma withdrawing its financial guidance.
The FDA plans to increase field tests in imported drugs by over 100 per cent and has requested a 19 per cent rise in its budget for 2010 to enable it to achieve this and other targets.
The FDA has provided a model for implementing the ICH Q10 quality control system in its final guidance, which is intended help manufacturers adapt processes throughout a product’s lifecycle.
The safety of drugs imported into the US remains high on the FDA’s agenda, with the agency publishing new draft guidance that raises standards for labs inspecting products made overseas.
Two approvals in a week for drugs made at Ranbaxy’s New Jersey OHM Laboratories subsidiary have eased the generics firm’s North American regulatory woes and strengthened its position in the expanding US market.
Yesterday’s US Supreme Court decision upholding a $7m damages award to a Vermont woman who sued Wyeth means that drugmakers are still vulnerable to State consumer liability lawsuits despite FDA approval for a drug and its labelling.
It is not compulsory to respond to form 483s detailing deficiencies at a facility but the FDAs latest guidance fully recommends companies do so to avoid being issued with a warning letter.
