The European Medicines Agency (EMA) has announced it will be providing “special support” to help drug developers use alternative approaches to animal testing through its Innovation Task Force (ITF). Such approaches include tests based on human and animal cells, organoids, organ-on-chips and insilico modeling, all of which have promise to be more predictive scientific tools.   The task force, established by EMA in 2014, is a horizontal cross-sectorial group that b...

As part of work under two executive orders, the US Food and Drug Administration's (FDA) centers on Thursday sought comments on which existing regulations and related paperwork requirements could be modified, repealed or replaced, to reduce the burden on industry while allowing FDA to continue its public health mission and fulfill statutory obligations. Back in February, when President Donald Trump first announced his order to reduce regulatory burdens, several exper...

In an email to agency staff on Monday, FDA Commissioner Scott Gottlieb said he will delay issuing layoff notices until after 30 September 2017, when the agency's current user fee agreements expire, if Congress has not passed legislation to reauthorize the agreements by then. Previously, FDA has said it would need to begin issuing layoff notices to thousands of employees that are funded by user fees if the agreements are not enacted by 1 August, as agencies are typically ...

President Donald Trump on Friday took another swipe at federal regulations, signing an executive order that requires all federal agencies to create task forces to help “alleviate unnecessary regulatory burdens placed on the American people.” The added layer of bureaucracy created by the executive order is called upon to, within two months, designate an agency official as its Regulatory Reform Officer (RRO). Each RRO shall oversee the implementation of regulatory reform ...

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 Advanced Medical Technology Association (AdvaMed) is at odds with a government task force over how unique device identifiers (UDI) could be used in a proposal for a coordinated registry network for medical devices. Background In 2012, the US Food and Drug Administration (FDA) issued a report, Strengthening Our National System for Medical Device Postmarket Surveillance , which detailed the agency's vision for improving device surveillance. One of the report's...

The US Food and Drug Administration (FDA) is teaming up with the US Centers for Medicare and Medicaid Services (CMS) to better regulate lab-developed tests (LDTs), which are currently overseen—haphazardly—by both agencies. Background The move is related to FDA's efforts late last year to regulate LDTs more similarly to traditional medical devices, and in particular in vitro diagnostics (IVDS). FDA has long maintained its authority to regulate LDTs, which are tests devel...

US regulators are once again reaching out to members of industry, this time seeking input on how the US Food and Drug Administration (FDA) facilitates the development of new antibiotics, and whether it could be doing more to help the pharmaceutical industry stay ahead of rising rates of antibiotic resistance. Background "Antibacterial drug development is critical to the public health and is an FDA priority," FDA explains in a new Federal Register posting. "We recogniz...

The US Food and Drug Administration (FDA) is preparing to launch a new FDA-only task force set on supporting the development of new antibacterial therapies, part of the provisions of the recently passed FDA Safety and Innovation Act (FDASIA) . The task force was prescribed as part of FDASIA's "Generating Antibiotic Incentives Now (GAIN)" title, intended to grant new incentives for developers of antibiotic therapies. Those incentives include additional years of marke...

Taking a page out of the anti-counterfeiters' playbook, a high-level Indian task force has recommended the adoption of verification technology and mobile text messaging authentication for medicines produced and sold in India, reports BioSpectrum Asia . The technology is already in use in some African countries such as Kenya and Ghana , but the adoption scale recommended by the Union Health Ministry's task force on pharmaceutical manufacturing would dwarf those in sca...

A study in the New England Journal of Medicine (NEJM) has prompted two Senators to call for a joint task force to be created. Sens. Olympia Snowe (R-ME) and Michael Bennet (D-CO) have requested that the US Department of Health and Human Services Convene a multi-agency task force to, according to The Hill journalist Julian Pacquet, "help identify patients at risk for adverse drug reactions." The request was inspired by a NEJM article that found that four types of m...