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  • Regulatory NewsRegulatory News

    House committee advances bills aimed at orphan exclusivity, generic labeling and continuous manufacturing

    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...
  • Regulatory NewsRegulatory News

    Proposed Precertification Approach on In Vitro Clinical Tests Raises Questions

    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 ...
  • Regulatory NewsRegulatory News

    Opioids Compromise: What’s in it for FDA

    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...
  • Regulatory NewsRegulatory News

    Senate Passes 'Right-to-Try' Bill

    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...
  • Regulatory NewsRegulatory News

    New Maryland Law to Restrict Generic Drug Price Increases

    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...
  • Regulatory NewsRegulatory News

    Maryland House Passes Bill on Price Gouging of Generic Drugs

    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...
  • Regulatory NewsRegulatory News

    Bipartisan House Bill Seeks to Repeal Medical Device Tax

    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 ...
  • Regulatory NewsRegulatory News

    House to Pass Revamped 21st Century Cures Bill

    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...
  • Feature ArticlesFeature Articles

    A Summary of 10 Years of Paediatric Legislation in the European Union

    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 ...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: UK Advances Bill to Stop Price Spikes on Generic Drugs (27 October 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Politicians Advance Bill to Close Drug Pricing ‘Loophole’ Legislation intended to close a drug pricing loophole in the United Kingdom has taken another step forward. The bill is designed to align two medicine price regulation schemes and, in doing so, give the government the power to stop companies from exploiting monopolies on generic drugs.   The UK runs paralle...
  • Regulatory NewsRegulatory News

    European Commission to Overhaul Concept of ‘Similar’ Medicines Within Context of Orphan Legislation

    The European Commission on Friday proposed to review the concept of “similar medicinal products” in the context of its orphan legislation as part of a wider effort to adapt the text to technical progress. Fifteen years after the implementation of the orphan legislation, the commission says it is currently launching initiatives to improve the implementation of the regulatory framework with a view to ensuring timely access to medicinal products.  In this context, the Comm...
  • Regulatory NewsRegulatory News

    Brexit Creating a Period of Uncertainty for EU, UK Drug and Device Regulators

    The fallout from the UK referendum is continuing to create strife among the ranks of the European Medicines Agency (EMA), though a top EMA official told the DIA annual conference on Tuesday in Philadelphia that business at the agency will carry on as usual as negotiations continue. Emer Cooke, head of international affairs at the EMA, said that the Brexit decision, which may cause the agency to leave London, “is a decision that affects a lot of the staff of the agency, p...