On April 23, 2013, the FDA launched a new website, FDA’s Patient Network. According to Margaret Hamburg, FDA Commissioner, the website is anticipated to “increase patient’s interest and participation in the agency’s work and in the policies and decisions that affect them.” The website was designed to make regulations clear to everyone and presents several categories from how to get in touch with FDA regulators to how to become informed about drug and device regulatory processes. The FDA hopes that the website will increase public involvement and open new lines of communication between the agency and the public. To read more on RAPS.org, click here.
Companies that produce generic drugs and APIs are required to self-identify to the FDA for FY2014 under the Generic Drug User Fee Amendments of 2012. The period extends from May 1 to June 1, 2013 and FDA uses the information to determine the cost for application reviews and inspections of companies. To read more on in-pharmatechnologist.com, click here. Need help with FDA registrations, contact us at 317.899.9341.
FDA is calling for an international consortium of cardiovascular registries to coordinate data from multiple disease registries for use in testing the efficacy and safety of medical devices per a recent article on RAPS.org. Patient registries have been used in the past to help regulators manage data from common diseases, as well as gather information to help guide clinical trial expectations. FDA’s international cardiovascular consortium model is based on the International Consortium of Orthopedic Registries (ICOR), which also links various member registries. According to FDA, the registry would serve to “allow for broad-based analysis and surveillance of medical device exposure and related clinical outcomes.” FDA is planning to hold a workshop to gain public input on the proposal and discuss how to implement the plan. To read the full article on RAPS.org, click here.
What do you think of the FDA proposal? Contact us at 317-899-9341 for help with your clinical trials.
The FY2014budget for FDA requests about $821M more than it received in FY2012 and part of the funding request is an additional $10M for inspections in China. Increasing foreign inspections of drug manufacturing sites will prevent unsafe drug products from entering the US. Additionally, the proposal requests the exclusivity period for brand-name biologics to decrease from 12 to 7 years in 2014, to save Medicare and Medicaid an estimated $3B over 10 years. To read more about the FY2014 budget request on in-pharmatechnologist.com, click here.
The FDA plans to issue draft guidance proposing that manufacturers of automated external defibrillators get agency approval. These devices provide early defibrillation to patients suffering from cardiac arrest, a leading cause of death in the United States. The FDA is not questioning the safety or quality of the devices, but believes regulation will ensure that the devices are safe and effective. To read the full article on usnews.com, click here. Contact us at 317-899-9341 for help with medical device regulations.
Although the FDA retains authority for drug approvals, advisory committees of non-agency experts review applications and safety studies, as well. However, finding members without conflicts of interest to serve on these committees is difficult for the FDA. Recently, Dr. Samuel Maldonado, Johnson and Johnson vice president and head of its Pediatric Drug Development Center of Excellence was asked to be removed from an advisory committee that was reviewing drugs for children, including Invega, which is manufactured by a J&J subsidiary. To read the full article, click here. Contact us at 317-899-9341 for help with your FDA regulatory filings.
According to a recent article on Pharmatimes.com, the FDA plans to issue guidance describing which medical apps on mobile devices will be subjected to FDA approval. With the advent of multiple new medical apps, the FDA plans to regulate mobile devices that perform jobs done by medical devices that already require FDA clearance or approval. According to Christina Foreman, director of the FDA’s device evaluation division, the goal of the regulation is to “foster technological innovation,” while ensuring that the apps are safe for the public. The FDA does not plan to regulate wellness apps, such as pedometers or heart-rate monitors. To read the full article, click here. Need help getting your medical device approved? Contact us at 317-899-9341.
FDA recently issued draft guidance, entitled “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements.” The guidance was issued to clarify when a change in a medical device product warrants a recall. Additionally, the guidance distinguishes and defines a product enhancement from a product recall. FDA is accepting comments until May 23, 2013. To read the full draft guidance, click here. To read a related article, click here. Need help with a medical device submission? Please contact us at 317-899-9341 to help with your submissions.
The FDA adopted a Q&A from the International Conference on Harmonisation (IHC) to clarify the industry guidance, “E3 Structure and Content of Clinical Study Reports” (IHC E3), according to a recent article on outsourching-pharma.com. The purpose of the Q&A is to help contract research organizations (CROs) and sponsors draft clear and concise clinical study reports. The Q&A addresses various points of confusion in the 1995 IHC E3 guidance, including definitions of key terms and how to properly display adverse event data in clinical study reports. To read the full article, click here. Need help with a clinical study? Contact us at 317-899-9341.
Industry professionals, academics and FDA all agree that the cost of drug development is unsustainable, according a recent article on the San Francisco Business Times. To tackle the problem, FDA is looking at ways to change the drug development process. At the Personalized Medicine Conference, FDA’s Dr. Janet Woodcock described some of the ways FDA is accelerating the clinical trial process. Woodcock discussed everything from creating standing trial networks to the new “breakthrough therapies” initiative process. According to Woodcock, the initiative could cut the drug approval process to one stage with 30 to 50 patients. She also mentioned the need for more collaboration between industry, academia and patient groups. To read the full article, click here. Need help with a clinical trial? Contact us at 317-899-9341.