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    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 ...
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    FDA issues Jynneos EUA to stretch monkeypox vaccine supply

    The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Bavarian Nordics’ 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 ...
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    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...
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    This Week at FDAThis Week at FDA

    This Week at FDA: EtO, user fee woes, and product specific guidances

    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 the Environmental Protection Agency (EPA) said it would publish a new rule by year’s end that could have serious consequences for the ethylene oxide (EtO) sterilizers and the medtech industry; the head of the US Food and Drug Administration (FDA) tried to assure staff he’s doing...
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    EPA lists potentially high-risk EtO plants, plans to finally publish air pollution rule by year’s end

    The US Environmental Protection Agency (EPA) has published a list of ethylene oxide (EtO) sterilization plants around the country that may be linked to increased cases of cancer in nearby communities. The agency also plans to publish a long-awaited rule later this year that could have serious consequences for medical device manufacturers as half of all US devices are sterilized with the gas.    On 3 August, the EPA announced it will finally publish a rule that stake...
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    EMA, HMA outline evolution of DARWIN EU real-world database

    The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) plan to launch an ambitious new database to collect real-world data (RWD) from a slew of studies that reviewers can reference for their regulatory decision-making.   Their joint Big Data Steering Group’s third workplan lays out a timeline to develop the Data Analysis and Real World Interrogation Network (DARWIN EU). According to the plan, by the end of this year, the research database will in...
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    Califf seeking Congressional assurance user fees won’t run out

    With only two months to go before user fee legislation runs out and no indication Congress will reauthorize it in time, FDA Commissioner Robert Califf sought to assure agency staff that he is doing his best to get certainty from lawmakers their jobs are not in jeopardy, according to a  letter to FDA employees dated 29 July.   “We are continuing to evaluate the situation, and to explore all potential options and scenarios,” said Califf. “Our latest estimates are that w...
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    This Week at FDA: New guidance on disposable manufacturing materials, Generic Drug Cluster report

    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, the US Food and Drug Administration (FDA) published a guidance that describes chemistry, manufacturing, and controls (CMC) postapproval changes related to disposable manufacturing materials that drug and biological product manufacturers can reference. The agency also publishe...
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    FDA proposes checklist to inform patients of LASIK surgery risks

    The US Food and Drug Administration (FDA) on Wednesday released draft guidance on conveying the potential risks with Laser-Assisted In Situ Keratomileusis (LASIK) laser products in labeling to better convey these risks to consumers.   On 27 July, FDA published a draft guidance titled Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations . As more potential side-effects of LASIK treatments have become known over the years, the agency hop...
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    FDA finalizes ANDA CRL, Orange Book Q&A guidances

    The US Food and Drug Administration has published a final draft guidance that addresses what’s expected when sponsors get complete response letters (CRL) to their abbreviated new drug applications (ANDAs). The agency also finalized another guidance explaining its responsibilities for maintaining and updating the Orange Book , which contains lists patent and exclusivity information for drugs with therapeutic equivalence evaluations.   On 22 July, FDA published two fina...
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    FDA explains the ins and outs of real-time oncology review program in new guidance

    Cancer drugs under development that show substantial promise over existing therapies and have simple study designs, as well as easy to interpret endpoints, may qualify for a head-start review from the US Food and Drug Administration (FDA). While the drug will ultimately be reviewed under the same user fee time frame as other products, it may help speed up the review process for sponsors.   On 22 July, FDA published a draft guidance titled, Real-Time Oncology Review (...
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    FDA loosens UDI requirements for lowest risk devices, extends deadline for others

    The US Food and Drug Administration is relaxing its unique device identified (UDI) rule requirements for low-risk class I consumer health products. Other class I and unclassified devices will still need to follow UDI requirements, though FDA announced it will extend its compliance deadline for those devices to 8 December 2022.   On 22 July FDA released a final guidance titled, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassifie...