The new medical device user fee deal includes the US Food and Drug Administration’s (FDA) total product lifecycle (TPLC) advisory program, or TAP, as well as new guidance development requirements and claw back provisions that let industry renegotiate fees. If signed into law as is, it would bring in $1.78-$1.9 billion over the next five years.   FDA finally published a commitment letter on 22 March summarizing the Medical Device User Fee Amendments (MDUFA V) deal i...

Congressionally authorized regulatory flexibility could provide medical device manufacturers with more options and help the US Food and Drug Administration (FDA) better monitor product safety and efficacy, according to Jeff Shuren, director of the FDA Center for Devices and Radiological Health (CDRH).   “There really is a need for more flexibility to have agile regulation,” said Shuren during a fireside chat on 22 March at the Duke-Margolis Center for Health Policy’s d...

This article provides an introduction to artificial intelligence (AI), its characteristics, and how those characteristics affect regulatory compliance. It also examines efforts to regulate the ethical aspects of AI in the EU, future legislative initiatives that may affect AI in medical devices, and the crucial role standards play in supporting legislation.*   Introduction Although different people may understand artificial intelligence (AI) differently, it has been...

The House Energy and Commerce Committee on Wednesday advanced 17 health-related bills for consideration by the House, several of which have implications for the US Food and Drug Administration’s (FDA) oversight of orphan drugs, imported medical devices and labeling.   (RELATED: House committee discusses bipartisan bills on orphan exclusivity, generic drug labels and more , Regulatory Focus 29 January 2020).   “These bills will expand coverage and access to car...

Comments submitted to Congress on a recent discussion draft for a new risk-based approach to the regulation of in vitro clinical tests (IVCTs) raised questions and concerns around the IVCT precertification framework. The IVCT draft legislation would provide regulatory standardization for FDA-reviewed tests and laboratory developed tests (LDTs)—most of which do not meet the same standards in analytical and clinical validation—whereas IVCT precertification would enable ...

The US House and Senate late Tuesday reached a consensus on a conglomeration of opioids legislation that will have far-reaching effects for the US Food and Drug Administration (FDA). Among the provisions that will affect FDA include allowing the agency to require prescription opioids to be packaged in a three- or seven-day blister packs, further collaboration with the Customs and Border Protection (CBP) to stop illegal opioids at the border, new public meetings and guid...

The Senate on Thursday passed via unanimous consent (meaning there was not actually a vote) a bill that claims to improve terminal patients' access to experimental drugs but, if passed in the House and signed into law, may further burden and undermine the US Food and Drug Administration (FDA). The bill is part of what's known as the "Right-to-Try" movement, which has been sweeping across state legislatures  (37 states now have such laws), and is part of a bid to in...

A new Maryland law to keep generic drug prices from increasing by too much goes a step further than price transparency bills and laws in other states, but it’s leaving some with more questions about its broader impact. Just before the weekend, Maryland Gov. Larry Hogan (R) allowed the generic drug price gouging bill, HB 631 , to become law, though he did not sign the bill and expressed reservations about "unintended consequences." In a letter to the Maryland Spea...

Late Monday, Maryland’s House of Delegates signed off on a bill seeking to prohibit companies from overcharging for generic drugs. Under the bill, the Maryland Medical Assistance Program would be required to notify manufacturers of an essential generic drug and the attorney general of a specified increase in the price of the essential generic drug. The bill would also require a manufacturer of an essential generic drug to submit a specified statement to the attorney gene...

Rep. Erik Paulsen (R-MN) and a group of more than 220 bipartisan representatives on Tuesday introduced a bill that would permanently repeal the 2.3% tax on medical device companies under the Affordable Care Act (ACA). While the ACA is likely to be repealed and possibly replaced in full by the 115th Congress, this bill ( HR 184 ) would make permanent a delay that kept the tax from taking effect through next year. President-elect Donald Trump also has said he supports ...

The US House of Representatives on Wednesday is poised to pass a wide-ranging bill that will overhaul certain aspects of the US Food and Drug Administration (FDA) and provide the agency with more funding. The 996-page bill, known as the 21st Century Cures bill  and released last Friday, has already earned praise from the White House and is likely to pass the Senate, which will take it up early next week. In addition to speeding up the approvals of new drugs, devices...

This article summarizes 10 years of experience with paediatric regulations in the EU. Introduction Almost 10 years ago, on 27 January 2007, new Paediatric Legislation (PL) came into force that reshaped the regulatory landscape for paediatric medicines in Europe. 1, 2 The objective of this Paediatric Regulation (PR) is to improve the health of children in the European Union (EU) by: facilitating the development and availability of medicines for children from birth ...