9 May 2013
By Jim Moran, Erika Stevens and Julie Statzel
This article discusses the history and primary principles of Good Clinical Practice (GCP), explaining that is much more than just a single document outlining the standards for clinical research. Read More...
4 April 2013
By Jim Moran, Erika Stevens and Christina Eberhart
Consider the following hypothetical situation: During a routine inspection, FDA requests and inspects investigational pharmacy policies and procedures as well as product accountability and handling. Were investigational products accounted for and stored appropriately? Does the investigational pharmacy have a quality management system or risk management policy? How are corrective and preventive actions tracked? Will the investigational pharmacy be cited with a Form 483? Read More...
7 August 2012
By S.K. Sahu, MPharm, PhD, and P.K. Nandi, MPharm
Drug Master Files (DMFs) are required in most countries as supporting documents for the registration of drug products. DMFs generally contain information pertaining to the chemistry, manufacturing and controls (CMC) sections of the drug submission and reflect the drug’s identity, strength, purity and quality. Read More...
6 August 2012
By Alexander Gaffney
The US Food and Drug Administration (FDA) sent more warning letters during 2011 than at any time during the previous 13 years, and FDA official told a San Francisco chapter meeting of the Regulatory Affairs Professionals Society (RAPS). Speaking at a 27 July meeting, Barbara Cassens, director of FDA's San Francisco District office, highlighted recent FDA enforcement trends, including warning letters, injunctions, arrests, convictions, and the most common deficiencies exhibited by medical device and pharmaceutical manufacturers. Read More...
24 July 2012
By Joseph McMillian, MA
When an audit is conducted, company management expectations are simple: They want to know whether there is a problem, how big it is and whether or not it is being fixed. All too often, audits, and their reflection in follow-up communications, fail to live up to that role because most audit processes and reports fail to take full advantage of, and communicate, the information they gather. However, without a denominator, the auditor and the audit report recipients will have difficulty determining an overall compliance profile for the site or the processes being audited. Read More...
28 June 2012
By Ron C. Falcone, PhD and Richard S. Levy, MD
Jakafi® (ruxolitinib) was approved by the US Food and Drug Administration (FDA) on 16 November 2011 for the treatment of intermediate or high-risk myelofibrosis (MF) including primary MF, post-polycythemia vera MF (PPV-MF) and post-essential thrombocythemia MF (PET-MF). Prior to this time, there were no approved products, and therefore no precedent for regulatory endpoints in this orphan disease. This case study describes the product's development and subsequent path through FDA. Read More...
1 November 2011
By Ira Asherman
Today’s regulatory professionals find themselves in an ever more complicated and challenging environment. Their core responsibility is to ensure their firm’s compounds move through the approval and labeling process as rapidly as possible.
The pressure to achieve this goal, among others, is constant and unrelenting, and the regulatory professional plays a central role in that process. He or she is the company’s representative in dealing with the governing agency as well as the person who translates the agency’s requirements and concerns back to his or her co-workers.
Everyone is concerned with how effectively the regulatory professional interacts with the agency. It is a process that everyone is watching and on which everyone has an opinion. Like it or not, the regulatory professional has a very critical and demanding audience. Read More...
1 November 2011
By Stefan Menzl, PhD, and Sibylle Scholtz, PhD
Today, mobile phones and mobile Internet access are widely used around the world. Information is available at all times and is just a “click” away.
But instructions for use (IFU) for most medical devices still must be printed on paper and included with every product. By most standards, this is an anachronistic way of informing people.
Will we deal forever with tons of IFUs in dozens of languages printed on precious paper? Or, will there be soon an alternative? Read More...