Regulators described how the parallel scientific advice (PSA) program offered by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) saves sponsors time and resources by bringing both health authorities to the table to hammer out solutions to complex scientific issues arising from their drug development packages at a 16 March webinar held by FDA’s Small Business and Industry Assistance (SBIA) program.   The goal of the PSA program is to ...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) recently issued two revised documents for its Manual of Policies and Procedures (MAPP): one addresses updated procedures for its data standards program and the other covers operational procedures for scientific interest groups (SIG).   The 10-page MAPP on data standards governance discusses the operating model to support the implementation of CDER’s data standards program. It r...

Regulatory Focus is pleased to team with Tarius , a regulatory information services provider, to routinely offer information about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner. Upcoming Meetings   13 September – Allergenic Products Advisory Committee   The committee will discuss and make recommendations on the safety and efficacy of Peanut [Arachis hypogaea] Allergen Powder manufactured by Ai...

Following thousands of patient lawsuits and a spike in adverse event reports, the US Food and Drug Administration (FDA) on Tuesday ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the US immediately. Since FDA reclassified surgical mesh products to class III (high risk) in 2016, the agency said the two manufacturers, Boston Scientific ...

While the US Food and Drug Administration (FDA) attempts to re-work its policy on off-label use communications, Rep. Morgan Griffith (R-VA) has introduced a new bill that would further allow pharmaceutical companies to discuss such uses with physicians. GOP representatives have criticized FDA recently for failing to update its policies on off-label use communications as the agency has lost several recent court cases on the issue , and has questioned the need for loos...

The European Medicines Agency (EMA) on Tuesday released a document discussing the regulatory support available to drugmakers looking to submit applications via the Article 58 procedure in an attempt to increase access to medicines in low- and middle-income countries (LMICs). Background First introduced in Regulation (EC) No. 726/2004 in 2004, the Article 58 procedure allows EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in collaboration ...

The European Medicines Agency (EMA) on Friday announced that it will launch a tailored scientific advice pilot project in February 2017 to support the development of new biosimilars. The tailored procedure will advise developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available (standard  scientific advice  does not include the assessment of existing data). EMA plans to run the pilot until ...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Posts new Guidance on Changing Risk-Management Plans, Manufacturing Sites The European Medicines Agency (EMA) has posted new guidance on post-authorization changes to risk-management plans (RMPs) and manufacturing sites. EMA, which has adopted the policies in an attempt to simplify processes for marketing authorization holders, explained the implications of the guidance...

The European Medicines Agency (EMA) on Tuesday released its Annual Report 2015 touting its performance and key achievements for the year. According to Sir Kent Woods, former chair of the EMA Management Board, 2015 was a year of transition for the agency. In November 2014, EMA Executive Director Guido Rasi's appointment was annulled , leaving the agency without a head until November of the following year when Rasi was re-appointed . Despite the disruption to EMA's le...

As part of efforts to streamline and strengthen regulatory pathways for global health products, the Global Health Technologies Coalition (GHTC) says in a new report issued Thursday that Congress should direct the US Food and Drug Administration (FDA) to establish a specific mechanism to offer a formal scientific opinion on medical products for their use outside the US. Because FDA is classified as a stringent regulatory authority, the agency’s review of drugs and devices...

The European Medicines Agency (EMA) says its pilot project for delivering scientific advice to sponsors in parallel with health technology assessment (HTA) bodies has been successful in helping to design efficient clinical development plans and speeding access to new drugs. Due to the success of the pilot, which concluded on Wednesday, EMA says it will continue to offer parallel scientific advice as part of its routine activities. "Our parallel scientific advice fosters...

The European Medicines Agency (EMA) on Monday launched its new PRIME (PRIority MEdicines) scheme which aims to streamline the development of promising new therapies that meet unmet medical needs. Like the breakthrough therapy program in the US, the new EMA program aims to accelerate the development of new drugs to treat rare cancers, Alzheimer's and other neurodegenerative diseases, AIDS and diabetes, among others. "I think we still see too many patients in desperate ne...