• Regulatory NewsRegulatory News

    FDA Collaborates With FTC on Mobile Health App Regulatory Tool

    The US Food and Drug Administration (FDA), the Federal Trade Commission (FTC) and other regulators are looking to help health-related mobile application developers comply with the Federal Food, Drug and Cosmetics Act (FD&C Act) and other applicable laws. As part of that compliance push, FTC on Tuesday released  a new web-based tool for developers of health-related mobile apps .  The tool asks developers a series of high-level questions about the app’s function, the da...
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    OPDP Untitled Letter Takes Issue With Shionogi's Copay Assistance Voucher

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) has found that Shionogi’s “Patient Co-Pay Assistance Voucher” for Ulesfia (benzyl alcohol) lotion to help treat head lice is false or misleading because it omits important risk information. The omission of such risk information means that the voucher misbrands Ulesfia within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and makes its distribution violative, ...
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    Harvard Professors Call for Science-Based Pharma Marketing

    Two Harvard professors are taking issue with the recent landmark court decision allowing some "truthful and non-misleading" off-label pharmaceutical marketing in a new paper, saying “informativeness in asserting scientific facts, rather than truthfulness, ought to be the gold standard for evaluating commercial speech about pharmaceuticals.” Background The US Food and Drug Administration (FDA) generally does not allow pharmaceutical companies to promote drugs for unappro...
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    FDA Sends Three Letters Over Unapproved Zika Diagnostics

    The US Food and Drug Administration (FDA) is taking steps to enforce its oversight of diagnostic tests used to detect the Zika virus, with three new letters to two laboratories and two Texas hospitals for marketing what it says are "high risk" unapproved diagnostics. The letters, sent to MD Biosciences, First Diagnostic Corp. and two Texas hospitals, Texas Children's and Houston Methodist Hospital, call on the recipients to contact the agency within seven days to discuss...
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    MHRA Takes Action on LinkedIn Pharma Marketing

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Friday said it has reprimanded the dermatology company Galderma after receiving an anonymous complaint about promotional material for a prescription drug shared on the social networking site LinkedIn. MHRA said it upheld the complaint as the UK, unlike the US, does not allow prescription-only medicines to be promoted to the public though it does allow advertisements for over-the-counter medicines, accor...
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    API DMFs for ANDAs: FDA Finalizes Guidance on Completeness Assessments

    The US Food and Drug Administration (FDA)'s final guidance issued on Friday will help the generic drug industry prepare for completeness assessments for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA). The guidance, first released in draft form in 2012 , lays out requirements for how companies will have to pay a DMF fee, which for FY 2016 is $42,170, when fi...
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    Generic Drug Review Dashboard: FDA Offers a First Look

    As Congress continues to push for the US Food and Drug Administration (FDA) to speed the approval of new generic drugs, which could be key for keeping pharmaceutical prices in check, FDA for the first time is offering an in-depth look at where it stands with industry’s abbreviated new drug applications (ANDAs). What’s clear from the new data on 2015 is that FDA continues to seek more information or require companies to correct what’s known as an “easily correctible defic...
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    DOJ: Device Manufacturers Can Relay ‘Truthful’ Info on Unapproved Uses

    A US Department of Justice attorney for the first time explained in a set of jury instructions that it is legal for a device company or its sales representatives to provide doctors with “wholly truthful and non-misleading information” about off-label medical device uses. The jury instructions, filed earlier this month by Richard Durbin, Jr., the US Attorney for the Western District of Texas, explain what speech is illegal under the Food, Drug, and Cosmetic Act (FDCA) in ...
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    FDA and EMA Share Perspectives on Evaluating Ebola Treatments

    Officials from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have shared their perspectives on evaluating treatments for Ebola in two articles appearing in Clinical Trials . The articles discuss some of the challenges the Ebola outbreak presented for studying drugs and vaccines to treat the disease. At the time the outbreak began, no products existed to treat Ebola, and those that were in development had not been tested in humans. Study ...
  • Feature ArticlesFeature Articles

    Registration Procedures for Medicinal Products in China

    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...
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    EMA Carries 2014 Momentum, Recommends 39 New Drugs and Sets Orphan Record

    In 2015, the European Medicines Agency (EMA) maintained its momentum from 2014 , granting 93 positive opinions, 39 of which were for new active substances. The agency also recommended 18 orphan drugs for approval, breaking last year's record of 17. Notably, EMA trailed just behind the US Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) for the year. In 2015, CDER approved 45 new drugs, 21 of which had been granted orphan drug designati...
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    Post-Marketing Plans: An Often Overlooked Component of FDA Advisory Committee Meeting Discussions

    The article analyzes the proportion of FDA Advisory Committees specifically asked to discuss or vote on issues related to post-approval safety activities. Introduction Preparing effectively for a US Food and Drug Administration (FDA) Advisory Committee meeting requires the sponsor team's anticipation of discussion and voting topics FDA will pose to the advisory panel. Discussion topics and voting questions will influence information the team provides to the panel as w...