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  • Regulatory NewsRegulatory News

    FDA Updates List of Brand Name Companies Blocking Generic Applicants

    Back in November 2017, FDA Commissioner Scott Gottlieb called on brand name drug companies to “end the shenanigans” around delaying or restricting generic drug competition. But that call to action has not stopped brand name companies from continuing to pursue at least one gaming tactic, which is refusing to provide samples to competitors looking to bring generic products to market. As part of an effort to deter such a tactic, FDA recently created and updated a list o...
  • Regulatory NewsRegulatory News

    FDA Draft Guidance Looks to Help Speed New Generics to Market

    The blitz of new US Food and Drug Administration (FDA) guidance (11 draft and final documents in the last three days) continued on Friday with the release of a draft helping to clarify for generic drug companies how to define and use several terms, and new ways to expedite generic approvals. In a shift in direction for the agency, and in order to speed the availability of generics, FDA “now will approve a generic drug for which it has made a final determination that the ...
  • Regulatory NewsRegulatory News

    Generic Drugs Should Look Similar to the Drugs They Reference, FDA Says

    The US Food and Drug Administration (FDA) is recommending drugs made by generic manufacturers closely mimic the physical attributes, including the size, shape and color, of the drugs they reference. Background When FDA approves an abbreviated new drug application (ANDA), it does so primarily on the basis of a drug's bioequivalence to the Reference Listed Drug (RLD), the drug to which the generic is compared. Data must show a drug contains the same active ingredient, in ...
  • Regulatory NewsRegulatory News

    FDA Says it Discovered Problems With Generic Version of ADHD Drug Concerta

    A generic attention deficit hyperactive disorder (ADHD) drug manufactured by Mallinckrodt has been found by the US Food and Drug Administration (FDA) to not be sufficiently equivalent to its reference drug, Concerta. Background Generic drugs are approved through FDA's abbreviated new drug application (ANDA) process. During that process, FDA is primarily concerned with data showing the generic drug is bioequivalent to the reference listed drug (RLD), sometimes referred t...
  • J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk

    Drug shortages have been a recurring problem in the US thanks to a combination of market factors, regulatory decisions made by the US Food and Drug Administration (FDA) and manufacturing problems experienced by companies. So in 2012, when Johnson & Johnson's oncology drug Doxil (doxorubicin hydrochloride liposome injection, NDA # 050718 ) started experiencing shortages, FDA unveiled an unusual plan . It would allow a similar drug, Lipodox (ANDA # 203263 ), made by ...
  • FDA Now Able to Temporarily Approve Generic Drugs Using Different Label than RLD

    The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), part of its Center for Drug Evaluation and Research (CDER), is out with the new policy that aims to clarify how its staff should implement a relatively new statutory provision that permits the agency to approve generic drugs even when labeling changes are happening with  its comparator product, the reference listed drug (RLD). Background The section in question, 505(j)(10) of the Federal Fo...
  • Senator Plans to Introduce Legislation Reversing Mensing Decision

    • 29 March 2012
    • By
    Senator Patrick Leahy (D-VT) moved earlier this week (26-30 March) to introduce legislation to overturn a loophole exposed by a recent Supreme Court case that Leahy claims "threatens the safety of consumers taking generic drugs." In Pliva v. Mensing , the Supreme Court ruled generic pharmaceutical manufacturers are not liable for tort claims based on labeling because federal law requires the drug's label to be identical to the Reference Listed Drug (RLD). "The  Me...
  • Petitions to Delay Generic Seroquel Denied

    Two petitions from pharmaceutical manufacturer AstraZeneca that could have delayed market competition to its flagship line of antipsychotic drugs were denied by the US Food and Drug Administration (FDA) on 9 March. AstraZeneca's Citizen Petitions requested that FDA delay market entry for generic products if those products omitted warnings about the risk of developing hyperglycemia. FDA required AstraZeneca to include such warnings on Seroquel and Seroquel XR (quetiapine ...
  • FDA: Tablet Size Matters for Generics

    The US Food and Drug Administration (FDA) is warning generics manufacturers with pending Abbreviated New Drug Applications (ANDAs) that their products must adhere to the Reference Listed Drugs' (RLD) tablet size, writes Kurt Karst at FDA Law Blog . The Office of Generic Drugs (OGD) wrote to several manufacturers that the non-uniform, larger tablets represented choking hazards, efficacy issues due to patient inability or unwillingness to swallow the tablet, and the p...