A pilot program intended to reduce the time between clearance and Medicare coverage for innovative medical devices will continue on indefinitely, the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced on Friday. The program, known as parallel review, allows device makers to request a simultaneous, overlapping review by the two agencies with the goal of reducing the time between receiving a pre-market approval (PMA) or t...

A national medical device evaluation system planning board, created in part by the US Food and Drug Administration (FDA), released a new report on Monday outlining how it plans to develop such a system and a center to coordinate such efforts. Both the national medical device evaluation system (NMDES) and the coordinating center are part of a larger goal of FDA’s to expedite the generation and dissemination of reliable medical device data, including real-world evidence, i...

The US Food and Drug Administration (FDA) is calling on private health insurers and other payer groups that use clinical data to inform coverage decisions to participate in medical device pre-submission meetings to facilitate timelier access to new devices. The agency believes that including coverage organizations, such as private insurers and health technology assessment (HTA) bodies, early on will allow those organizations to discuss clinical trial design and evidence ...

The US Food and Drug Administration (FDA) is giving manufacturers more time to remove drug codes from certain medical device labels in compliance with unique device identifier (UDI) requirements to avoid disrupting patient access to devices. Specifically, the agency says it will enforce a statutory prohibition on National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers for device labels and packaging for certain devices. In 2013, FDA issued its fin...

The National Institute of Standards and Technology (NIST) is launching a project to improve the cybersecurity of wireless infusion pumps. To do so, NIST's National Cybersecurity Center of Excellence (NCCoE) is looking for vendors to provide it with the components and technical expertise required to simulate the hospital environment in which infusion pumps operate. In a notice published in the Federal Register Monday, NIST said the goal of the project is to help health...

This article provides a high-level introduction to the Chinese regulatory framework, including requirements for marketing approval of imported drugs. An increasing number of pharmaceutical companies based outside China are interested in marketing their products in China as evidenced by the increasing number of clinical trial and marketing applications submitted by foreign companies. Obtaining marketing authorization approval equal to an Import Drug License (IDL) approv...

A group of 51 lawmakers are calling on the National Institutes of Health (NIH) to issue guidance on when "march-in rights" could be used to bypass patents on drugs developed using federal funding. In a letter led by Rep. Lloyd Doggett (D-TX) to Department of Health and Human Services (HHS) Secretary Sylvia Burwell and NIH Director Francis Collins today, the lawmakers call on NIH to "utilize [its] existing statutory authority to respond to the soaring cost of pharmaceutic...

This article reviews the Draft National Medical Device Policy (NMDP-2015) proposed by the government of India and evaluates potential pros and cons of its most important feature. On 3 June 2015, the Indian government developed a draft National Medical Device Policy ( NMDP-2015 ), which was made public for review by all stakeholders. 1 The objective of NMDP—2015 is "to strengthen the Make in India drive, a government initiative to promote manufacturing sector in ...

Patients in the UK with a specific form of non-small-cell lung cancer (NSCLC) will get early access to AstraZeneca's Tagrisso (osimertinib), following a positive opinion by the Medicines and Healthcare products Regulatory Agency (MHRA). Specifically, patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC will be able to access Tagrisso under the Early Access to Medicines Scheme (EAMS). EAMS was created to provi...

The Medical Device Regulatory Affairs (MDRA) Graduate Certificate Program , a joint academic program from RAPS and the School of Biomedical Engineering at the National University of Singapore (NUS), graduated its first cohort of 31 students last month. The program was developed in partnership with several of Singapore’s government agencies as part of the country’s efforts to nurture a highly competent regulatory workforce. Singapore has spent much of the past de...

Last year, RAPS and the National University of Singapore (NUS) launched a joint graduate certificate program in Medical Devices Regulatory Affairs (MDRA) for Singapore-based regulatory professionals. The program was developed in partnership with Singapore’s government as part of its effort to help cultivate the highly competent regulatory workforce needed to support the country’s growing medical technology industry. The first year of the MDRA certificate program ...

The National Institutes of Health (NIH) says it is working quickly to figure out how to correct major deficiencies uncovered by the US Food and Drug Administration (FDA) last month at one of its drug compounding facilities. Background On 4 June 2015, NIH issued a statement saying it had "suspended operations" at its Pharmaceutical Development Section (PDS) following an inspection by FDA that found "a series of deficiencies." PDS is NIH's pharmaceutical development arm,...