• 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...
  • Regulatory NewsRegulatory News

    FDA Official: EU privacy regulations impede BIMO inspections, application reviews

    According to a US Food and Drug Administration (FDA) lawyer, the European Union’s privacy regulations are a headache for researchers and regulators trying to share data. Heather Messick, the former lead policy analyst on the EU’s General Data Protection Regulation (GDPR) at FDA’s Europe Office, says the regulation has created major roadblocks to sharing patient data needed to review premarket applications and reporting adverse events.   The EU GDPR went into effect in ...
  • Regulatory NewsRegulatory News

    Study: Accelerated approval pathway working as intended in most cases

    Over the last several decades, the US Food and Drug Administration’s (FDA) accelerated approval program has largely been working as it was designed to, with about half the products using the pathway being converted to traditional approvals, according to a recent analysis from a group of authors at Amgen published in Therapeutic Innovation & Regulatory Science .   About half of accelerated approval products went on to receive traditional approval at a median of 3.2 yea...
  • Regulatory NewsRegulatory News

    FDA issues Jynneos EUA to stretch monkeypox vaccine supply

    The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Bavarian Nordic's monkeypox vaccine Jynneos to be administered to adults intradermally. The move is meant to significantly increase the availability of the vaccine because it requires much smaller doses compared to being injected subcutaneously.   Immediately after Health and Human Services (HHS) Secretary Xavier Becerra issued a determination under Section 564 of the Federal ...
  • Regulatory NewsRegulatory News

    Drugmakers request changes to FDA’s mass balance studies guidance

    The pharmaceutical industry is calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on radiolabeled mass balance studies, suggesting the guidance be revised to require fewer subjects, and mention a male preference for these studies, with exceptions for females of non-child-bearing age. One manufacturer recommended that antibody drug conjugates (ADCs) be excluded from these studies.   The comments were submitted in response to FDA’s draft ...
  • Regulatory NewsRegulatory News

    Legal Expert: Too early to tell if SCOTUS ruling will chill FDA regulation

    When the majority of the US Supreme Court (SCOTUS) in late June said that an Obama-era Environmental Protection Agency (EPA) policy to curb climate change was a regulatory overreach, legal experts wondered if it would have a chilling effect on the Food and Drug Administration’s (FDA) ability to regulate industry. According to a legal expert, it’s still too early to tell what the impact on FDA will be, though there are several areas where the agency may see challenges based...