• ReconRecon

    Recon: Biden admin embarks on effort to develop next-gen COVID-19 vaccines; EU approves Bavarian Nordic’s Monkeypox vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House to launch effort to develop next generation of Covid vaccines ( STAT ) ( Barrons ) FDA puts the microscope on 2 more cancer approvals without voluntary withdrawals ( Fierce ) Biden administration weighs declaring monkeypox a health emergency ( Washington Post ) ( Reuters ) Monkeypox ‘Can Be Contained” in US, White House Doctor Says ( Bloomberg ) S...
  • Regulatory NewsRegulatory News

    FDA describes plans to expand remote regulatory assessments

    The US Food and Drug Administration (FDA) released draft guidance on Friday that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as it eases out of pandemic response mode. The guidance covers triggers for when FDA will request or require remote assessments and how these audits will be coordinated with onsite inspections.   These tools are not intended to replace onsite inspections but inste...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Remote regulatory assessments guidance, 12-digit NDCs, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, FDA released its long-awaited guidance on how it plans to incorporate remote regulatory assessments across product areas going forward. The agency also issued a proposed rule to adopt a uniform 12-digit format for national drug codes (NDCs) and updated its list of medical devic...
  • Regulatory NewsRegulatory News

    FDA warning letter tells Spanish API firm to up its validation game

    A Spanish producer of active pharmaceutical ingredients (API) was chastised by the US Food and Drug Administration (FDA) in a June 30 warning letter for its spotty approach to validation and ensuring that manufacturing processes remain in a state of control and can consistently produce a quality product.   The letter to Bioiberica SAU in Barcelona, Spain, which makes heparin-based products, in addition to APIs, follows an inspection between 31 January and 4 February ...
  • Regulatory NewsRegulatory News

    Concerns rise that Congress may miss budget, user fee renewal deadlines

    With just over two months to go, it’s increasingly looking like Congress is going to miss its deadlines to pass a final US Food and Drug Administration appropriations bill and a user fee reauthorization bill.   On 20 June, Democrats in the US House passed a $400 billion “minibus” appropriations bill in a 220-207 vote that largely split down party lines. That means it’s now up to the Senate to pass a similar bill, but lawmakers in the upper chamber haven’t even publicly...
  • ReconRecon

    Recon: Roche CEO to step down after 14 years; WHO to roll out first malaria vaccine in Africa

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Officials reorganize HHS to boost pandemic response ( Washington Post ) ( Reuters ) ( Politico ) Worried by Supreme Court, U.S. House votes to protect contraception ( Reuters ) Biden picks renowned cancer surgeon Monica Bertagnolli as NCI chief ( STAT ) President Biden tests positive for Covid-19, but has ‘very mild symptoms’ ( STAT ) Biogen agrees to pay $90...
  • RoundupsRoundups

    Euro Roundup: MHRA misses performance targets amid resource constraints, Brexit backlogs

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) missed multiple performance targets for its 2021-2022 financial year due to resource constraints, Brexit backlogs, and additional reasons.   MHRA started the financial year aiming to produce 97% of validation reports for new marketing authorization applications within 14 days of case creation; instead, the agency achieved the 14-day target 83.4% of the time.   “Embedding centrally authorized products...
  • Regulatory NewsRegulatory News

    Dose banding: FDA aims to reduce drug waste in new labeling guidance

    The US Food and Drug Administration (FDA) has released draft guidance to assist sponsors with incorporating dose banding information in drug labeling for ready-to-use containers in new drug applications (NDAs), biologics license applications (BLA) or supplements to those applications.   Dose banding refers to dosing a drug product based on weight or body surface area (BSA), and labeling can include a range of different strengths.   This approach reduces “signific...
  • Regulatory NewsRegulatory News

    FDA offers new guidance on therapeutic equivalence evaluations

    In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment of therapeutic equivalence codes, which are listed in the agency’s Orange Book and provide information about whether drugs are bioequivalent and can be substituted for one another.   “Therapeutic equivalence evaluation have been prepared to serve as public information and advice to state health agencies,...
  • ReconRecon

    Recon: CDC clears fourth COVID-19 vaccine; Merck’s Keytruda hit with setback after failed head and neck cancer trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A fourth Covid vaccine is cleared for use in the United States. ( NYT ) ( STAT ) ( Reuters ) ACIP Nod For Novavax’s COVID Vaccine Comes With Criticism On Lack Of Expiration Date Packaging ( The Pink Sheet ) FDA carryover funds to pay staff to last until November, Burr says ( Politico ) FDA slaps ImprimisRx with a warning letter over sponsored articles in medic...
  • Regulatory NewsRegulatory News

    Pharmaceutical industry groups suggest modifications to ICH Q9 guideline

    Pharmaceutical industry groups in the US suggested the International Council of Harmonization’s (ICH) Q9(R1) guideline on risk management be revised to better reflect the principles of the ICH Q10 guideline on effective quality management systems. Industry groups in the US and the Europe also recommended that forthcoming training materials provide more concrete examples showing how specific risk management principles can be applied.   These comments were in response ...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA posts 2022-2023 priorities for import, advertising, supply compliance

    Australia’s Therapeutic Goods Administration (TGA) has published its compliance priorities for imports, advertising and supply. The list of priorities, which is topped by actions against unapproved COVID-19 products, covers the agency’s 2022 to 2023 financial year.   The list includes seven compliance priorities. First up: to “deter and address the unlawful import, advertising and supply of unapproved therapeutic goods associated with COVID-19.” To do so, TGA will prov...