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  • Feature ArticlesFeature Articles

    Update on RMAT designations

    This article discusses the scope and purpose of the special designation for regenerative medicine advanced therapies (RMAT) created by the passage of the 21st Century Cures Act. The authors explain the benefits expected to be realized with RMAT and provide a tally of products receiving the special designation to date and a current count, by year, of products for which RMAT designation has been requested.   Introduction Section 3033 of the 21st Century Cures Act, titl...
  • Regulatory NewsRegulatory News

    Electronic device submissions addressed in FDA guidance

    A new final guidance from the US Food and Drug Administration (FDA) lays the framework for electronic submissions for medical devices. The agency advised that more specifics about the nuts and bolts of electronic submissions, as well as the timing of implemention, will be provided in upcoming guidances.   One guidance document is insufficient for describing and implementing electronic formats for all types of submissions covered under the statutory requirements, said F...
  • RoundupsRoundups

    FDA Approvals Roundup: Qwo, Tremfya, Dysport

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Qwo nabs approval for first injectable cellulite treatment Endo International’s Qwo (collagenase clostridium histolyticum-aaes [CCH] injection) has been approved as the first injectable therapy for moderate to severe cellulite in adult women.   The approval was based on findings from two identical double-blind, placebo-controlled trials in...
  • Regulatory NewsRegulatory News

    FDA adds three tropical diseases to PRV list, rejects two

    Three new conditions were added today to the list of tropical diseases for purposes of obtaining a tropical disease Priority Review Voucher (PRV) from the US Food and Drug Administration (FDA). The agency added brucellosis to the list, as well as two foodborne trematode infections, opisthorchiasis and paragonimiasis.   The agency determined that two other diseases, coccidioidomycosis and clonarchiasis, did not meet statutory criteria for tropical disease designation un...
  • Regulatory NewsRegulatory News

    FDA updates COVID-19 therapeutics website

    The US Food and Drug Administration (FDA) has to date reviewed over 230 trials of potential therapeutics to treat the novel coronavirus (COVID-19), according to a blog post by FDA commissioner Stephen Hahn, MD and colleagues. Over 510 COVID-19-directed drug development programs have reached the planning stage.   In the blog, agency officials provide an update on FDA’s Coronavirus Treatment Acceleration Program (CTAP), a set of resources designed to allow cross-agency...
  • Regulatory NewsRegulatory News

    House spending bill would give FDA drug recall authority

    The US House Committee on Appropriations approved a $3.212 billion budget for the Food and Drug Administration (FDA) on a voice vote Thursday. The budgeted amount is part of the fiscal year 2021 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill, which moved out of the Appropriations Committee on a voice vote.   The bill will now be placed on the calendar for consideration by the full House of Representatives. (RELATED: House prop...
  • Regulatory NewsRegulatory News

    FDA finalizes guidance on broader cancer trial eligibility

    In four final guidances published today, the US Food and Drug Administration (FDA) outlines cancer trial eligibility criteria considerations for individuals with several specific clinical conditions. Another guidance addresses minimum age considerations for inclusion of pediatric patients in cancer clinical trials.   The guidances, issued jointly by FDA’s Centers for Drug Evaluation and Research and Biologics Evaluation and Research (CDER and CBER), provide considerati...
  • Regulatory NewsRegulatory News

    ICMRA outlines shape of Phase 3 COVID-19 vaccine trials

    A new report provides a roadmap for Phase 3 clinical trials for developers of candidate vaccines for the novel coronavirus SARS-CoV-2, the virus that causes COVID-19. The report indicates which clinical and preclinical data will indicate a vaccine is ready for Phase 3 trials; it also lays out key considerations in designing Phase 3 clinical trials of vaccines for COVID-19.   The report reflects consensus reached at a 22 June 2020 teleconference convened by the US Foo...
  • Regulatory NewsRegulatory News

    More metformin recalled for NDMA; 6 firms now affected

    Two manufacturers have announced voluntary recalls of metformin formulations containing elevated levels of a potential carcinogen.   Granules Pharmaceuticals, based in Virginia, has issued a recall for its extended-release metformin, although just one of 12 batches tested exceeded acceptable levels of N-nitrosodimethylamine (NDMA) in the firm’s testing. The recall includes 100- and 500-count bottles of 750 mg metformin tablets.   Separately, India-based Lupin Pha...
  • RoundupsRoundups

    FDA Approvals Roundup: Rukobia, Byfavo, Inqovi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Rukobia gets the green light for hard-to-treat HIV ViiV Healthcare’s Rukobia (fostemsavir) has been approved for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant infection whose current antiretroviral regimen is ineffective because of resistance, intolerance, or safety concerns.   The drug, a ...
  • Regulatory NewsRegulatory News

    Updated: Device manufacturers warned by FDA for consumer complaint handling

    The US Food and Drug Administration (FDA) today released warning letters to two medical device manufacturers who, according to the agency, failed to address serious consumer complaints adequately. The agency also warned an India-based manufacturer of active pharmaceutical ingredients (API).     Luminex Corporation   Texas-based Luminex Corporation manufactures microsphere-based and PCR-based multiplexing systems; the firm was warned after a February 2020 inspec...
  • Regulatory NewsRegulatory News

    House proposes $3.2 billion for FDA in FY 2021

    On Monday, the US House Committee on Appropriations’ Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a markup session for fiscal year 2021 appropriations.   Of the total budget of $23.98 billion – a 2.3% increase from the prior fiscal year -- the bill allocates $3.212 billion for the Food and Drug Administration (FDA). This amount is an increase of $40.8 million over the prior fiscal year’s approximate $3.2 bill...