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  • Regulatory NewsRegulatory News

    FDA issues 36 new and revised product-specific guidances

    The US Food and Drug Administration (FDA) on Friday released its latest batch of product-specific guidances, posting 19 new and 17 revised draft guidances, bringing the total number of product-specific guidances issued by the agency to 1,938.   The guidances , which FDA posts quarterly, are intended to promote 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...
  • Regulatory NewsRegulatory News

    FDA explains transfer of ownership policy for generics

    The US Food and Drug Administration (FDA) has issued a new manual of policies and procedures (MAPP) for transferring ownership of drug applications, including those due to corporate mergers and acquisitions.   The new MAPP outlines how Orange Book staff in the Office of Generic Drugs will process requests to transfer ownership of a drug application and explains the responsibilities of the current owner of the drug application as well as the new owner.   To transf...
  • Regulatory NewsRegulatory News

    October, no surprise: COVID-19 vax AdComm booked for the 22nd

    The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee plans to meet on 22 October to discuss matters related to authorization and licensure of vaccines for COVID-19. No application will be on the docket at that meeting.   The announcement via the Federal Register and the FDA’s Twitter account comes a day after the head of the key US vaccine research accelerator Operation Warp Speed (OWS) signaled that a COVID-19 vaccine m...
  • Regulatory NewsRegulatory News

    FDA addresses nitrosamines in TB drugs

    Nitrosamine impurities have now been found in two tuberculosis drugs, prompting the US Food and Drug Administration (FDA) to clarify how it will handle elevated levels of the potential carcinogen in life-saving antibiotics.   Both rifampin and rifapentine are antibiotics used to treat tuberculosis, and rifampin is also used to treat other serious bacterial infections. Elevated levels of nitrosamines have been found in samples of both substances: the nitrosamine 1-methy...
  • Regulatory NewsRegulatory News

    FDA drafts recommendations for studying cancer drugs in patients with CNS metastases

    The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing recommendations to drugmakers on evaluating cancer drugs in patients with central nervous system (CNS) metastases.   FDA says the guidance is meant to inform clinical trial designs to support product labeling that describes antitumor activity of drugs or biologics in patients with CNS metastases from solid tumors originating in other parts of the body.   "There are few effectiv...
  • RoundupsRoundups

    FDA Roundup: Kyprolis, Kesimpta, Cystadrops

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Kyprolis in triple combo approved for previously treated multiple myeloma Amgen’s Kyprolis (carfilzomib) has received an expanded indication as a once- or twice-weekly combination with Janssen’s Darzalex (daratumumab) and dexamethasone for relapsed or refractory multiple myeloma in patients previously treated with immunomodulatory drug based (...
  • Regulatory NewsRegulatory News

    Updated: FDA delays collection of drug manufacturing volume data

    The US Food and Drug Administration (FDA) on Monday announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are “critical...
  • Regulatory NewsRegulatory News

    Cord blood firm warned by FDA on Zika screening

    A warning letter from the US Food and Drug Administration (FDA) warned a Puerto Rico-based firm for multiple violations related to human umbilical cord blood collection.   Banco Vida Corporation, located in San Juan, was inspected in September 2019 by investigators from FDA’s Center for Biological Evaluation and Research (CBER).  The increased risk for Zika virus for residents of Puerto Rico makes blood products from those individuals ineligible for use in human cell, ...
  • Regulatory NewsRegulatory News

    Study: FDA details high global drug quality

      A quality improvement study led by the US Food and Drug Administration (FDA) found that over 200 difficult-to-manufacture drug product samples met US standards for dosage unit uniformity and dissolution.   The 252 products that were sampled in the largest such study to date included 35 innovator and 217 generic drug samples. In all, the products contained 17 different active pharmaceutical ingredients (APIs) and the samples originated from 46 firms.   Adam Fish...
  • Regulatory NewsRegulatory News

    ANDA consolidation process updated in new MAPP

    The US Food and Drug Administration (FDA) has updated its manual of policies and procedures (MAPP) for the review of requests to consolidate previously approved generic drug applications.   The revised MAPP , entitled “ Consolidation of ANDAs by the Office of Generic Drugs ,” replaces the original October 2015 version of the document. The revisions clarify the process for sponsors of Abbreviated New Drug Applications (ANDAs) who wish to consolidate several ANDAs for d...
  • Regulatory NewsRegulatory News

    FDA revokes umbrella EUA for some patient barrier enclosures

    On 20 August, the US Food and Drug Administration (FDA) revoked the umbrella emergency use authorization (EUA) it had previously issued for passive, non-negative pressure protective barrier enclosures that are intended to be a physical barrier preventing healthcare provider exposure to airborne pathogens.   The EUA was issued on 1 May 2020 during the public health emergency of the coronavirus pandemic.  The passive protective barriers included in the EUA, consisting ...
  • Regulatory NewsRegulatory News

    FDA qualifies decision tool for breast reconstruction studies

    The BREAST-Q Reconstruction Module now is qualified as a medical device development tool (MDDT) to aid sponsors and investigators in developing feasibility, pivotal and post-approval studies of medical devices used in breast reconstruction, the US Food and Drug Administration (FDA) announced. “An MDDT is scientifically validated and can be qualified for use in device evaluation and to support regulatory decision-making,” according to the announcement , which noted its ...