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    FDA guidance spells out acceptance criteria for synthetic peptide ANDAs

    The US Food and Drug Administration (FDA) issued a final guidance on its criteria for accepting abbreviated new drug applications for synthetic peptide drugs of recombinant DNA (rDNA) origin.   The guidance is meant to spur the development of these complex drugs.  The agency also rejected industry calls to eliminate the impurity limit thresholds for accepting these submissions as abbreviated new drug applications (ANDAs).   The guidance, which finalizes 2017 draft ...
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    FDA releases batch of 21 product-specific guidances

    The US Food and Drug Administration (FDA) on Wednesday issued 13 new and eight revised draft product-specific guidances intended to facilitate the development of generic drugs.   The guidances are intended to foster generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug (RLD). FDA’s current count of product-specific guidances sits at 1,896 with this latest release....
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    FDA finalizes QIDP Q&A guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on its qualified infectious disease product (QIDP) designation program.   The 12-page guidance finalizes a draft version released for comment in 2018 and includes a revised question and answer section providing clarification on the types of products the agency considers to be antibacterial or antifungal drugs for the purposes of the designation. (RELATED: FDA Drafts Q&A Guidance on QIDP Designati...
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    FDA welcomes alternative approaches to generic drug development

    Issuance of a product specific guidance should not “diminish innovation or creativity” in generic drug development, Robert Lionberger, director for the office of research and standards in the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Generic Drugs, said at a 5 May webinar on the development of product specific guidance.   FDA officials said that the number of a product specific guidances (PSGs) issued by the Office of G...
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    CHMP recommends eight new medicines in April, including two orphans

    In its April meeting, the European Medicines Agency’s (EMA’s) human medicines committee recommended eight new medicines for approval, including three new non-orphan medicinal products and two orphan medicines.   EMA’s Committee for Medical Products for Human Use (CHMP) also issued positive opinions for extensions of therapeutic indications for nine medicines, bringing the total new indications for 2021 to 23.   Leo Pharma’s Adtralza (tralkinumab) was recommended ...
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    FDA offers guidance on generic drug development during COVID

    The US Food and Drug Administration (FDA) on Monday released a new questions and answers guidance for generic drugmakers addressing generic product development and abbreviated new drug application (ANDA) submissions and assessments during the COVID-19 public health emergency.   “FDA recognizes that the COVID-19 public health emergency may impact the development of generic drug products, interrupt or delay ANDA applicants’ bioequivalence studies, and impact the submissi...
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    FDA issues 36 new and revised product-specific guidances

    The US Food and Drug Administration (FDA) this week issued 36 new and revised draft product-specific guidances meant to facilitate the development of generic drugs by clarifying the agency’s expectations for the studies required to demonstrate bioequivalence (BE) to a reference listed drug (RLD).   The latest batch of guidances includes 22 new and 14 revised draft guidances covering drugs to treat prostate cancer, hepatitis C, multiple sclerosis and numerous other cond...
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    FDA unveils plans to tackle COVID variants

    The US Food and Drug Administration (FDA) on Monday unveiled recommendations for vaccine, drug and diagnostic test developers to address the impact of COVID-19 variants on the efficacy and performance of their products.   The recommendations are made across four new and updated guidances targeting vaccines , drugs and biologics , monoclonal antibodies and diagnostic tests .   “The purpose of these guidances is to address the emergence and potential future emer...
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    CBER lays out scaled-down guidance agenda for 2021

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has released its list of draft and final guidances it plans to issue in 2021.   The list contains just 14 guidances, half of which will be draft documents, down from 31 guidances in 2020 and 20 guidances in 2019. Of those 14 guidances, only a few are new additions to the list, with the remainder being carried over from the previous year.   CBER was able to cross more tha...
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    FDA eyes adaptive designs for BE studies impacted by COVID-19

    The US Food and Drug Administration (FDA) is looking to adaptive designs to salvage in vivo bioequivalence (BE) studies that have been disrupted by the COVID-19 pandemic.   FDA acknowledged the impact that the public health emergency could have on BE studies early in the pandemic and in April 2020 the agency created a webpage with information for abbreviated new drug application (ANDA) sponsors noting that protocol revisions may be required for studies that are inter...
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    CDER lays out 2021 guidance agenda

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released a list of the new and revised draft guidances it plans to release in 2021.   The agenda, while oftentimes aspirational, provides insights as to what the agency’s drug center’s new guidance priorities are for the coming year. However, the list does not include draft or revised guidances the agency plans to finalize in 2021. (RELATED: 2020 CDER draft and revised guidance...
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    A look at FDA’s data on priority and competitive generics

    Three years into the second Generic Drug User Fee Amendments (GDUFA II) program, the US Food and Drug Administration (FDA) has seen the number of priority and competitive generic therapy (CGT) abbreviated new drug applications (ANDAs) approved or under review rise as generic drugmakers continue to pursue both designations. The FDA Reauthorization Act of 2017 (FDARA), which reauthorized GDUFA for five years, includes provisions to shorten the reviews of certain ANDAs...