• Regulatory NewsRegulatory News

    FDA Scraps Pregnancy Labeling Classification System in Favor of New Standard

    The labeling on many prescription drug products approved after 2001 will need to be reconfigured to include clearer information about whether a drug is safe to use during pregnancy, the US Food and Drug Administration (FDA) announced today. Background Prescription drug labeling has been subject to standardization measures in the US since 1979, when measures to introduce labeling uniformity were first passed. Those measures were substantially updated in 2006 under FDA's ...
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    Generic Drug Industry Threatens FDA With Lawsuit Over Drug Labeling Proposal

    The generic pharmaceutical industry's most prominent trade body, the Generic Pharmaceutical Association (GPhA), is threatening to sue the US Food and Drug Administration (FDA) if the agency finalizes a change in its labeling regulations that would make it easier for generic drug companies to update their product's labels in response to adverse events. Background Under the Federal Food, Drug and Cosmetic Act (FD&C Act) , generic drug products must—with minor exceptions—...
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    DEA, Following FDA Recommendation, to Toughen Regulation on Popular Class of Painkillers

    In a long-anticipated move, the Drug Enforcement Administration (DEA) has announced it will now regulate all hydrocodone combination products as Schedule II drugs under federal law. The move follows an October 2013 recommendation by the US Food and Drug Administration (FDA), which also recommended that the drugs be regulated as Schedule II products under the Controlled Substances Act (CSA), a 1970 law which places controls on substances known to be dangerous, prone to ...
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    Pharma Company's Phone Script Violates Advertising Regulations, FDA Says

    Those who closely track so-called "Untitled Letters" authored and sent by the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) know the letters most frequently reference promotions made over two types of media: the Internet and print media. But in an unusual letter sent last week by OPDP, the office indicated that it's still keeping an eye on promotions made using a decidedly traditional format: the telephone. An Untitled Letter In i...
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    House Republicans Increase Pressure on FDA Proposal, Citing Agency's 'Dubious' Behavior

    A new group of House legislators is calling on the US Food and Drug Administration (FDA) to answer questions about a plan to overhaul the way in which generic drug labels are updated to reflect new safety risks, saying the plan appears to have been improperly influenced by a special interest group. Background In November 2013, FDA unveiled a new proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products . The rule wou...
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    Senators Say FDA Import Regulation Would Harm Vulnerable Consumers

    • 10 July 2014
    Four US senators are pressuring the US Food and Drug Administration (FDA) to walk back a rule proposed by the agency in May 2014 that would make it more difficult to import unapproved drugs into the US. Background The proposed rule, Administrative Destruction of Certain Drugs Refused Admission to the United States , is meant to tweak the agency's pharmaceutical import provisions under Section 801(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under the ...
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    Regulators Extend Comment Period on Proposed Overhaul of Device Reclassification System

    The US Food and Drug Administration (FDA) is extending by several months the comment period on a proposed rule which would make it easier for the agency to classify and reclassify medical devices in accordance with their perceived risk. Background The proposed regulation is required under a 2012 law known as the  Food and Drug Administration Safety and Innovation Act (FDASIA) .  Section 608 of the law  called for FDA to be given the authority to make classificati...
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    FDA Releases New Animal Rule Guidance With Focus on Vaccines and Animal Health

    The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens. Background In 2002, Congress authorized and FDA passed the Animal Efficacy Rule ("Animal Rule"), a regulation which permits the approval of some products based on safety testing...
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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...
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    FDA Down-Classifies Colon, Intravascular Devices

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has proposed that two medical devices marketed prior to the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act) be subject to less stringent regulation. In two separate Federal Register announcements, FDA said it would permit intravascular administration sets and colon capsule imaging systems, respectively, to be classified as Class II devi...