• RoundupsRoundups

    Asia-Pacific Roundup: Philippines seeks feedback on abridged review of clinical trial applications

    The Philippine Food and Drug Administration (FDA) seeks feedback on draft guidelines on the abridged regulatory review of clinical trial applications. In creating the text, FDA has drawn heavily on a draft released for consultation in May, while excluding rare diseases, cancer and HIV/AIDS from the list of eligible therapeutic areas.   The effort is based on FDA’s push to increase reliance on the work of other regulators. Last year, the World Health Organization rele...
  • Regulatory NewsRegulatory News

    Experts: Lack of EU reference labs due to regulatory uncertainties, COVID workload

    The European Commission is having a difficult time getting member states to offer up European Union reference laboratories (EURLs) to review high-risk in vitro diagnostics (IVDs) under the In Vitro Diagnostic Medical Devices Regulation (IVDR). Industry experts say lack of clear regulations and the COVID-19 pandemic may be behind the dearth of candidates.   The EC sent a call out to member states in the European Economic Area (EEA) in July seeking EURLs to help revi...
  • Regulatory NewsRegulatory News

    UK MHRA is first to authorize Moderna’s bivalent COVID-19 booster

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Moderna’s bivalent COVID-19 booster vaccine for adults. The vaccine’s composition is split evenly between components targeting the original 2020 SARS-CoV-2 strain and those targeting the Omicron BA.1 variant.   On 15 August, UK regulators announced they’ve approved the new Moderna mRNA vaccine, known as mRNA-1273.214, that they expect will be even more effective in targeting currently cir...
  • Regulatory NewsRegulatory News

    FDA warns two Massachusetts infusion pump makers owned by same CEO

    Two infusion pump manufacturers were handed similar warning letters for multiple issues, including failing to take adequate corrective actions after receiving product complaints, following up on those complaints and addressing product failures. The companies are owned by Chaoyoung Lee and headquartered at the same address in Massachusetts.   On 9 August the US Food and Drug Administration posted warning letters it had sent to infusion pump-makers Zyno Medical , dated ...
  • ReconRecon

    Recon: UK’s MHRA is first to approve bivalent COVID booster; Brainstorm to seek FDA approval for ALS treatment, despite agency’s concerns

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers' shares stabilize after Zantac litigation slump ( Reuters ) In a momentous vote for Pelosi, House sends drug pricing reforms to President Biden’s desk ( STAT ) Analysis: US move to negotiate drug prices a rare defeat for Big Pharma ( Reuters ) Newly-launched US drugs head toward record-high prices in 2022 ( Reuters ) Emergent receives FDA warning l...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Amazon warning letter, ANDA amendments, 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, we take a look at warning letters sent to online retail giant Amazon and two other companies for selling unapproved drugs for mole and skin tag removal. Plus, FDA has opened a public docket to gather feedback on its abbreviated new drug application (ANDA) amendments guidance, ...
  • Regulatory NewsRegulatory News

    Expert: OGD on track to approve more generic drugs in FY2022

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) will most likely approve a higher number of generic drugs in FY2022 compared to the prior year, and the number of generic applications received may continue to exceed OGD’s review capacity, asserted Robert Pollock, a senior advisor with Lachman Consultants.   Pollock, who regularly writes about FDA’s generic approvals, spoke to Regulatory Focus and shared these observations in his recent blog ...
  • Feature ArticlesFeature Articles

    The value of a ready-to-use therapeutic food guideline for severe malnutrition

    Ready-to-use therapeutic foods (RUTFs) are used in the treatment of children with severe acute malnutrition (SAM) without medical complications. This article focuses on the value of an RUTF guideline. Knowing what is required for children with SAM helps manufacturers produce safe, efficacious, and good quality products, which will ultimately benefit end users. It will also help with the evaluation of products and provide guidance for researchers or innovators.   Keywo...
  • Regulatory NewsRegulatory News

    FDA blasts California firm for multiple GLP issues involving nonclinical studies

    The US Food and Drug Administration (FDA) found a slew of good laboratory practice (GLP) violations during the conduct of nonclinical studies at West Sacramento, CA firm Valley Biosystems in a 3 August warning letter and blasted the firm for not following its own procedures governing animal welfare, inadequate staff training, data integrity issues and inadequate reporting of nonclinical studies.   The warning letter was sent to the West Sacramento, CA, based firm ove...
  • ReconRecon

    Recon: PhRMA weighs legal options as US pricing reforms move through Congress; Europe to consider dose-sparing to increase monkeypox vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US The fight is on: As US pricing reform advances through Congress, pharma gears up for a brawl ( Fierce ) ( Endpoints ) Pediatric Disincentive? Implications Of US Pricing Bill ( Pink Sheet ) Amid Roche and Sanofi's oral SERD setbacks, Menarini gets speedy review at FDA ( Endpoints ) Drugmakers Hunt for One Vaccine to Target All Covid Variants ( Bloomberg ) Monkeyp...
  • Regulatory NewsRegulatory News

    FDA-led study highlights tradeoffs in drug promotion on social media

    Providing both benefit and risk information within character-space-limited (CSL) drug promotions on social media platforms like Twitter improved recognition of risks but made it less likely that consumers would click links for additional information on the drug, according to a series of experimental studies led by the US Food and Drug Administration (FDA).   “Although it can be challenging to add risk information to CSL communications, this research supports FDA guidan...
  • RoundupsRoundups

    Euro Roundup: MDCG posts guidance on notified bodies

    The Medical Device Coordination Group (MDCG) has posted guidance on the designation, reassessment and notification of conformity assessment bodies and notified bodies.   MDCG created the guidance to support designating authorities responsible for assessing applications for medical device and in vitro diagnostic notified bodies. The text also covers the reassessment and is intended to “bring consistency and to align the working practices of the different designating aut...