The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells. FDA officials presented their proposal to pilot the databases last week during a meeting of the Recombinant DNA Advisory Committee (RAC), which is organized by the National Institutes of Health's (NIH...

A recent study funded by the US Food and Drug Administration (FDA) found that an iPod Touch-based platform and FDA's Sentinel system could be used to accurately track the safety of drugs and vaccines dispensed during public health emergencies. The platform, called the handheld automated notification for drugs and immunizations (HANDI), uses an application running on an iPod touch, fitted with a card reader and barcode scanner, to record patients' information from a drive...

The US Food and Drug Administration (FDA) on Friday unveiled briefing documents that could support the approval of Celltrion’s proposed Remicade (infliximab) biosimilar ahead of next Tuesday’s advisory committee hearing. The 73-page document offers new insight into what Celltrion submitted to support the licensure of its biosimilar, known as CT-P13, for Johnson and Johnson’s reference product, and FDA officials noted that the two products are “highly similar,” though th...

[Editor's note: RAPS will be hosting an eCTD workshop 13-14 April. More details here .] Regulatory Focus Interviews Steve LoCastro and Sharen Johnson, West Pharmaceutical Services For pharmaceutical companies, filing Common Technical Documents (CTDs) is a critical aspect to the regulatory approval process. Historically, this process has been paper-centric until recently. This exclusive interview features a recent collaborative effort between West Pharmaceutical Ser...

The US Food and Drug Administration (FDA) is “almost certain” to require clinical data in order for companies to demonstrate interchangeability between a biosimilar and its reference product, though the question of how much data will be required is major factor in determining how quickly the US biosimilars market will take off, according to a new report from the law firm Goodwin Procter. The Biologics Price Competition and Innovation Act (BPCIA) of 2010 established th...

Three Johns Hopkins researchers are calling on the US Food and Drug Administration (FDA) to take action on expensive off-patent drugs by permitting bulk compounding and importation of generic formulations of the drug that are approved in other countries. Typically, when a drug goes off-patent and generic versions become available, the price of the drug goes down significantly. Sometimes, due to limited demand or low returns, the market for a particular generic becomes un...

Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday. The communications between FDA and industry are often opportunities to share cirtical information on clinical trials and for the agency to provide advice on trial design, dose selection...

Beginning today, the European Medicines Agency (EMA) will require companies to use new electronic application forms (eAF) for all medicines applying to the centralized procedure. Background In March 2012, EMA piloted the use of electronic application forms as part of its efforts to modernize the marketing authorization process. Since then, EMA has allowed companies to submit their initial marketing authorization applications in either electronic or paper format. Then i...

The European Medicines Agency (EMA) is conducting user-acceptance testing of new electronic application forms (eAF) in preparation for the transition to electronic-only applications on 1 July 2015. Background In February, EMA announced it would require all new human and veterinary medicines using the centralized procedure, including variations and renewals, to use eAFs as opposed to paper applications. EMA began using electronic application forms for marketing au...

Within two years, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically, the regulator announced this week. Background FDA has received electronic submissions from drug companies since at least 2003, when it adopted the International Conference on Harmonisation's (ICH) electronic common technical document (eCTD). The submission standard is used by many of the world's top regulatory bodies, incl...

The US Food and Drug Administration (FDA) is coming under fire from patient safety groups and US legislators who say the agency's attempt to require certain drug labeling information to be distributed electronically instead of on paper "package inserts" could put patients at risk. Background In December 2014, FDA released a long-anticipated proposed regulation, Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Prod...

New guidance issued by the US Food and Drug Administration (FDA) could make it easier for companies to conduct clinical trials by explaining how federal regulators will permit companies to use electronic media like interactive websites to help facilitate the informed consent process. Background In the US, clinical trials are regulated by FDA and the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under Chapter 21, Section 50.25 of the Code of Federal Regulations (...