• Regulatory NewsRegulatory News

    One of FDA's Top Device Regulators Stepping Aside

    One of the US Food and Drug Administration's (FDA) top medical device regulators, Christy Foreman, will soon be giving up her position to focus on tobacco regulation at the agency. In an announcement on 19 August 2014, FDA said that Foreman—now director of the Office of Device Evaluation (ODE), the office which oversees approval of all medical devices in the US—will soon assume a new, as-yet undefined role at FDA's Center for Tobacco Products (CTP). Foreman's last day...
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    FDA Targets Companies for Facebook 'Likes.' Is Twitter Next?

    Over the last two years, two companies have found themselves in the sights of the US Food and Drug Administration (FDA) after the regulator warned them for violating federal advertising regulations by "liking" unapproved claims on the social networking website Facebook. But while FDA's warnings have yet to set off a wider crackdown on pharmaceutical companies, recent changes to the social media platform Twitter have raised the possibility that similar attention might so...
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    Regulatory Explainer: What You Need to Know About the Regulation of Ebola Treatments

    Unless you've been living under a rock this month, you've undoubtedly heard about a massive outbreak of the Ebola virus in western Africa. The virus is poorly understood, exceedingly rare and, most importantly, incredibly deadly. But what you probably haven't heard about is how treatments for Ebola are regulated—an oversight we at Focus are keen to correct. In this Regulatory Explainer , we're taking a look at the regulations that surround the development of a pote...
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    In Major Shift, FDA to Regulate Lab-Developed Tests as Normal Devices

    The US Food and Drug Administration (FDA) announced Thursday that it plans to reverse a decades-old policy and begin regulating Lab-developed Tests (LDTs) more similarly to in vitro diagnostic devices (IVDs). Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval through the premarket approval (PMA) process—a difficult and expensive pathway that requires clinical data to support an application—or a...
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    House Legislators Clear Sunscreen Innovation Bill, but Questions Remain

    The US House of Representatives has voted in favor of a bill that would require the US Food and Drug Administration (FDA) to speed up its assessment process for new sunscreen ingredients that have been awaiting regulatory approval for as long as a decade in some cases. Background The bill, the Sunscreen Innovation Act (H.R. 4250) requires FDA legislators to speed up their review of sunscreen ingredients submitted under the Time-and-Extent Application (TEA) process. ...
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    India’s CDSCO Releases New Clinical Trial Guidelines

    India’s Central Drugs Standard Control Organisation (CDSCO) has released a slew of orders making a wide range of changes to the agency’s policies governing clinical trials.  New policies stated in the documents include: Sponsors, investigators, the regulator and Ethics Committees are responsible for ensuring that the design of placebo-controlled trials is appropriate, efficient and ethical; Investigators are limited to working on a maximum of three trials simultan...
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    Medical Device Data Systems to be Exempt from Regulation, FDA Says

    In a stark reversal, US Food and Drug Administration (FDA) regulators today said they would exempt medical device data systems (MDDS)—systems used to collect and store data from other medical devices like weight scales and glucose meters—from regulation, abandoning an earlier plan to regulate them as Class I ("low-risk") medical devices. The announcement comes more than three years after FDA down-classified MDDS devices from Class III ("high-risk") to Class I. Whil...
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    Sunscreen Innovation Act Advances in House, Seeks FDA Action on New Ingredients

    Legislators are preparing to move forward with legislation that would require the US Food and Drug Administration (FDA) to take action on the approval of new sunscreen ingredients, a collection of which have been pending before the agency for years, and in some cases more than a decade. Background HR 4250 , known as the Sunscreen Innovation Act , is co-sponsored by Reps. Ed Whitfield (R-KY) and John Dingell (D-MI) and required FDA legislators to speed up their r...
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    Final Rule Seeks More Stringent Regulation of Tanning Lamps

    The US Food and Drug Administration (FDA) has issued a final rule which will regulate ultraviolet lamps used for tanning more stringently, reflecting the lamps' association with skyrocketing rates of skin cancer. Background At present, sunlamp products—commonly used in tanning beds—are Class I medical devices that are exempt from premarket review procedures. The devices have been marketed since before the 1976  Medical Device Amendments , which effectively regulated me...
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    Final Regulation Makes it Easier for FDA to Seize Drugs at the Border

    The US Food and Drug Administration (FDA) is finalizing without change a proposed regulation introduced last year which would establish an administrative detention process for pharmaceutical products it believes are adulterated or misbranded. Background The rule is borne from the  Food and Drug Administration Safety and Innovation Act (FDASIA) , Section 709 ("Administrative Detention") of which ordered FDA to promulgate a final regulation within two years of the passage...
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    Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting

    The US Food and Drug Administration (FDA) has released an updated list of regulations it is planning to seek in 2014, known as its "Unified Agenda," outlining six new rules it says it intends to propose in 2014. DQSA-Related Rules Several are related to FDA's new authority under the Drug Quality and Security Act (DQSA) of 2013, which contains numerous provisions intended to enhance FDA's ability to regulate compounding pharmacies. For example, FDA plans to issue pro...
  • FDA Moves to Close Glaring Loophole in Current Drug Import System

    A proposed rule issued by the US Food and Drug Administration (FDA) would make it easier for the agency to destroy low-value drugs refused admission into the US under federal law. Background: Import Regulation The backbone of pharmaceutical regulation in the US is the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under Section 801(b) of the FD&C Act , FDA is permitted to refuse to allow the import or entry of any drug that has not been approved (under Sect...