• Regulatory NewsRegulatory News

    Breaking Down Barriers to Drug Innovation a Team Effort, FDA Says in Guidance

    A new guidance document just finalized by the US Food and Drug Administration (FDA) aims to clarify how pharmaceutical companies and the public can help accelerate drug development through the agency's Critical Path Initiative (CPI). Background FDA's Critical Path Initiative was created in March 2004 as an attempt to identify and dismantle unnecessary roadblocks to new product innovation and regulatory approval. These roadblocks, which would exist on a product's "critic...
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    Leveraging Expedited Programs for Drugs and Biologics for Serious Conditions and Rare Diseases

    In recent years, the US Food and Drug Administration (FDA) has made great advances in the review of new drugs. The US now is reported to lead the world in both timeliness and quantity of noteworthy new drug approvals. 1 This trend is due in part to FDA’s ongoing commitment to improve the drug development process and establish robust, efficient and predictable development programs. As a result, products demonstrating a positive benefit-risk profile and appropriate e...
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    UK Regulator Touts its Involvement in Domestic Manufacturing Site

    The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is once again touting its efforts to bolster manufacturing innovation, releasing a case study explaining its role in the redevelopment of a local manufacturing site. Background In 2013, MHRA launched its Innovation Office, with the goal to provide advice and assistance to companies working on novel treatments or manufacturing processes. The Innovation Office encourages companies to contact them e...
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    Under Pressure from Congress, FDA Holds Firm on Rejection of new Sunscreen Ingredients

    Despite congressional pressure to approve several new sunscreen ingredients long pending before reviewers, the US Food and Drug Administration (FDA) says it will not bow to pressure and will instead continue to insist the companies provide it with data to show the products are both safe and effective. Background FDA's regulation of sunscreen ingredients popped up as a major issue starting in late 2013, when sunscreen manufacturers banded together to form a coalition ...
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    Medical Device Group Mirrors Congress in Efforts to Improve FDA Regulation

    The US's largest medical device trade group, AdvaMed, has unveiled a new "Innovation Agenda" it hopes will complement legislative efforts meant to improve the way in which the US Food and Drug Administration (FDA) regulates medical devices. Background The agenda, released on 10 February 2015, is part of a larger push to "renew [the] medical technology innovation ecosystem," AdvaMed explained in a press statement. The ultimate goal of the initiative is to "help speed pat...
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    Senate Launches Bipartisan Effort to Assess, Change how FDA Regulates Medical Products

    The US Senate's Health, Education, Labor and Pensions (HELP) Committee is in the early stages of launching its own legislative process intended to help reform the ways in which the US Food and Drug Administration (FDA) regulates drugs and medical devices, it has announced. Background The effort, announced on 29 January 2014, is being led by Sens. Lamar Alexander (R-TN) and Richard Burr (R-NC), and is meant to complement similar efforts by the House Energy and Commerce ...
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    Senator Wants Companies Who Break FDA Regulations to Help Fund NIH

    US Sen. Elizabeth Warren (D-MA) has unveiled plans to introduce new legislation she says will require pharmaceutical companies found guilty of regulatory and legal non-compliance to pay large fines, all in the hopes of providing a new funding stream to the National Institutes of Health (NIH). The Premise: Big Profits Come From Government In a speech at a healthcare conference on 22 January 2015, Warren—a populist Democrat whose meteoric rise to popularity has left some ...
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    Six Drugs Selected to Advance in EMA's Adaptive Pathways Pilot Program

    The European Medicines Agency (EMA) recently announced that it has selected six drugs to move forward in its adaptive pathways (formerly adaptive licensing) pilot program. Background In March 2014 EMA announced it would be launching an adaptive pathways pilot program that would seek to accelerate patient access to drugs intended to treat serious unmet medical needs. The adaptive pathways program would allow drugs to receive approval for use with a narrow indication o...
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    Bill Seeks Creation of New Pathway for Antibiotic Drug Approvals

    New legislation would allow the US Food and Drug Administration (FDA) to approve some antibiotics through a special "limited use" regulatory pathway, all in the hope of bringing more antibiotics to market to help fight antibiotic-resistant bacteria. A Limited Population Pathway The bill, the Promise for Antibiotics and Therapeutics for Health (PATH) Act , was introduced on 10 December 2014 by Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT). At its core, the legis...
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    Obama Approves Bill Reforming Regulation of Sunscreen Ingredients, Other Drugs

    US President Barack Obama has signed into law a new bill set to change the way in which some drugs, and in particular sunscreen ingredients long approved in other countries, are regulated by the US Food and Drug Administration (FDA). Background The bill, the Sunscreen Innovation Act (SIA), was signed into law by Obama on 26 November 2014 following its passage in the House of Representatives on 14 November 2014. The bill's passage follows extensive complaints by s...
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    Bill to Speed up Approvals for Sunscreen Ingredients, Other Drugs Awaits Obama's Signature

    US legislators in the House of Representatives have passed a Senate bill which would overhaul the manner in which the US Food and Drug Administration (FDA) approves sunscreen ingredients and other products through a rarely used regulatory pathway known as the Time-and-Extent process (TEA), all but assuring the bill will be passed into law. Background The bill, known as the Sunscreen Innovation Act (SIA) , follows extensive complaints by several companies that their sun...
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    Breaking Bottlenecks: FDA Clarifies Tool for Expediting Drug Development (Corrected)

    The US Food and Drug Administration (FDA) is trying to clarify how industry can request a meeting of the agency's Critical Path Initiative (CPI), a decade-old effort to accelerate drug development through the use of common standards. Correction: A previous iteration of this article suggested that FDA's effort under the Critical Path Initiative, as well as its Critical Path Innovation Meetings (CPIM), were connected with the Critical Path Institute (C-Path)—a public-priv...