• Feature ArticlesFeature Articles

    July’s Regulatory Focus: Real-world data, real-world evidence

    Feature articles during July focused on real-world data and evidence (RWD and RWE) and their application to approval processes, labeling, clinical use, and marketing of medical products. Articles examined RWD and RWE in the context of patient outcomes and regulatory challenges, especially when conducting noninterventional studies (NIS); regulatory application of RWD-generated external comparators; and from an interregional perspective in the EU, US, and Japan. Also include...
  • Feature ArticlesFeature Articles

    Considerations for regulatory application of RWD-generated external comparators

    Properly designed and analyzed external comparators (ECs) built from real-world data (RWD) and the resulting real-world evidence (RWE) can be compared in certain situations with data generated from single-arm or traditional randomized clinical trials to support regulatory decisions. Proper development, design, and use of ECs requires more than simple matching of the clinical trial inclusion and exclusion criteria within the RWD source. A focus on the specificity of the res...
  • Regulatory NewsRegulatory News

    Devices Referencing Drugs: Questions Raised Over Potential Regulatory Pathways

    The US Food and Drug Administration (FDA) on Thursday held a public hearing to look into the scientific, regulatory and legal challenges posed by devices referencing drugs (DRDs) and the agency's proposed approach to regulating such products. Specifically, DRDs are medical devices that reference an already-marketed drug when the drugmaker does not want to work with the device sponsor to pursue the new use. FDA says it sees three situations where DRDs could be proposed: ...
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    How Price Caps in India are Forcing US Device Companies to Sell Stents and Implants at a Loss

    Hypothetical talk circulating on Capitol Hill this week around the idea of price ceilings for certain pharmaceuticals set off alarm bells for industry. But on the medical device side, companies are already seeing what happens when a government, in this case India, sets price caps for certain devices and mandates that companies remain in the market and take a loss on sales. The situation in India has reached a point where the Advanced Medical Technology Association ...
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    HHS Secretary Tom Price Resigns

    • 29 September 2017
    Friday afternoon, the White House announced the resignation of HHS Secretary Tom Price and his replacement of Don Wright as the acting secretary. His resignation follows numerous questions related to his use of private jets and their mounting cost to the US taxpayer. Politico first broke the story of Price’s use of the charter planes more than a week ago. Price, who was sworn in in February and was the former chairman of the House budget committee, served as secret...
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    States Take on Drug Price Transparency, Gouging

    As the US Congress continues to highlight specific drug price increases rather than adopt wide-reaching legislation to curb such practices, states are taking the matter into their own hands. In California, an Assembly committee on Wednesday moved forward a bill ( SB 17 ) that would shine a spotlight on what the state spends on the most expensive prescription drugs, as well as which drugs have seen the highest year-over-year spending increases. The bill, which pa...
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    Generic Industry Group Sues Maryland Over Price Gouging Law

    The Association for Accessible Medicines (AAM), a trade group representing US manufacturers of generic drugs and biosimilars, on Thursday sued Maryland over a new law that will impose fines on generic drugmakers if prices rise by too much or too quickly. Maryland Gov. Larry Hogan (R) allowed the generic drug price gouging bill,  HB 631 , to become law in June, though he did not sign the bill and expressed reservations about "unintended consequences" as well as "le...
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    FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition

    The US Food and Drug Administration (FDA) took major steps toward increasing generic drug competition on Tuesday by releasing a list of off-patent pharmaceuticals with limited or no competition, and by prioritizing the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug. Both moves seek to increase generic drug competition and lower the cost of pharmaceuticals in the US. The generic dr...
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    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...
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    HHS Secretary Pushes to Cut FDA Appropriations, Replace With More Industry Fees

    Secretary of Health and Human Services (HHS) Tom Price is continuing to push the Senate to further increase the industry fees paid to the US Food and Drug Administration (FDA), which would upend the agreed-to amounts negotiated by FDA and industry for the next five years, and allow for further cuts to the agency’s congressional appropriations. Last week, the Senate Health, Education, Labor & Pensions (HELP) committee advanced a bill reauthorizing the user fee pro...
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    Asia Regulatory Roundup: TGA Plans to Bolster its Punishment Powers (9 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. NPPA Ratchets up Pressure on Abbott, Medtronic to Keep Supplying Stents The National Pharmaceutical Pricing Authority (NPPA) of India has stepped up its attempts to stop Abbott Healthcare and Medtronic from curbing supply of their high-end cardiac stents. NPPA’s latest move is to encourage hospitals, doctors and patients to tell it if there is a shortage of certain br...
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    Sen. Wyden to HHS: Upcoming FDA Opioid Meeting Full of Conflicts of Interest

    Sen. Ron Wyden (D-OR) is requesting that the US Food and Drug Administration (FDA) delay a workshop on opioids because of the financial conflicts between opioid manufacturers and those participating in the event, according to a letter sent Friday to HHS Secretary Tom Price. The workshop , set for Tuesday and Wednesday, is intended to obtain input on the issues and challenges associated with federal efforts to support training on pain management and the safe prescr...