This article details how regulatory professionals can measure the quality of the outputs generated from the quality department. Additionally, the terms Quality Assurance (QA), Quality Control (QC) and quality management are often erroneously used interchangeably. Included are details about how these terms differ. So often we hear about how important quality is and that companies take pride in their quality or are focused on quality. It is one thing to suspect or to try...

The US Food and Drug Administration's (FDA) top negotiator for the fourth iteration of the Medical Device User Fee Act (MDUFA IV) presented changes to the funding mechanisms of the program at a public meeting at FDA's White Oak Campus on Wednesday. Last week, FDA released its draft recommendations for changes to its user fee program for medical devices which would allow the agency to collect roughly $999.5 million— an increase of $320 million over the previous five-yea...

A host of biosimilar experts, industry representatives and US Food and Drug Administration (FDA) officials convened on Thursday to discuss the second iteration of the Biosimilar User Fee Act (BsUFA II) and iron out the specifics of how the program needs to adapt over the next five years as the number of biosimilar applications continues to increase. FDA Commissioner Robert Califf opened the public hearing with comments on how the agency is still trying to find the righ...

This article provides an overview of the new FSMA regulations and suggests some recommended steps to prepare for inspections, including preventive controls, supply chain management and good record keeping practices. Introduction Without question, the US Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) is the most significant food safety law of our generation. The original Federal Food, Drug, and Cosmetic Act of 1938, included a single sentence ...

More than a year after the pharmaceutical and biotech trade groups began voicing their opinions and crafting the next iteration of the US Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA), and both PhRMA and BIO have said they are pleased with the performance goals outlined by and for the agency from 2018 to 2022. Background On 15 July, the US Food and Drug Administration (FDA) released for comment a  46-page document  outlining how the agency ...

Although the performance and procedural goals for the sixth iteration of the Prescription Drug User Fee Act (PDUFA ) were laid out last month, pharmaceutical companies, including AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the program from fiscal years 2018 through 2022. Background On 15 July, the US Food and Drug Administration (FDA) released for comment a 46-page document outlining how the agency will use t...

The US Food and Drug Administration (FDA) and representatives of the biotechnology industry have reached an agreement on the second iteration of the Biosimilar User Fee Act (BsUFA II) following 14 meetings from March through May. Specifically, the two sides have settled on the draft commitment letter that represents the agreements made over the course of the negotiations, which initially began in December 2015. Similar to FDA's other user fee programs, BsUFA is a ...

The Senate Judiciary Committee on Tuesday held a meeting with a panel of experts to discuss a recently introduced bill that seeks to stop branded drug companies from misusing Risk Evaluation and Mitigation Strategies (REMS) to withhold access to drug samples for bioequivalence testing necessary for bringing generic drugs to market. Background The bill, known as the CREATES Act and introduced last week , focuses on two tactics often employed by the branded drugmakers to...

Members of the Senate Judiciary Committee introduced bipartisan legislation on Tuesday that seeks to stop anticompetitive practices brand name drug companies often use to thwart or delay the entry of less-expensive generic versions of their products. Backed by 19 physician, pharmacist, hospital and consumer groups, including the Generic Pharmaceutical Association (GPhA), Public Citizen and the largest US pharmacy benefit manager, Express Scripts, the bill, known as the ...

At a congressional hearing in Washington, DC on Tuesday, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that current incentives are not enough to overcome the challenges of developing new drugs to fight bacterial infections. Antimicrobial resistance (AMR) is increasingly being recognized as a global threat to public health. In its 2014 Antimicrobial Resistance: Global Report on Surveilla...

As the US Food and Drug Administration (FDA) continues to debate whether to allow Britain’s Oxitec to release genetically modified mosquitoes into Florida and other vulnerable areas as a means of controlling the spread of the Zika virus, the company’s CEO told a House committee Wednesday that time is running out. Oxitec CEO Hadyn Parry, who testified before the House Committee on Science, Space and Technology, told the representatives that the company’s GM mosquito is sa...

Negotiations over the fourth iteration of the Medical Device User Fee Act (MDUFA) continued late last month and into May, with the US Food and Drug Administration (FDA) outlining plans for a new user fee proposal linked to real-world evidence (RWE). The RWE proposal is part of FDA’s counter proposal for the reauthorization of MDUFA, which was presented to industry on 4 March, and would cost $329 million above the cost of MDUFA III. In a meeting on 25 April (the meeting ...