ACI’s Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products – West Coast Edition
FDA Law Blog: Biosimilars
JULY 22, 2024
s John W.M. s John W.M.
2022 Packaging Regulations 
Analysis Chemical Thank You PFAS regulation in California (late 2023 edition)
Agency IQ
SEPTEMBER 15, 2023
PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. In 2019, the state began to significantly ramp up its PFAS regulation and research.
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Zebrafish Value Proposition for Cosmetic Testing
biobide
NOVEMBER 20, 2023
Background on the Cosmetics industry In 2022, the value of the global cosmetics market was estimated to be worth USD 262.21 Additional contributing factors include an increased awareness of fashion trends, innovations in the areas of hair coloring and skincare product formulations, and developments in the area of packaging.
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Article Periodic Thank You Commission unveils “one substance, one assessment” reform package
Agency IQ
JANUARY 19, 2024
Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals.
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Analysis Chemical Thank You California publishes draft regulations for landmark plastic pollution reduction act
Agency IQ
MARCH 15, 2024
California publishes draft regulations for landmark plastic pollution reduction act CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. By 2028, the state will require the recycling of 30% of single-use packaging and food service ware.
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Regulatory Developments in Ophthalmology: Applying New FDA Guidance, Part One
The Premier Consulting Blog
MAY 4, 2023
billion in 2022 and is expected to grow approximately eight percent from 2023 to 2030 [1]. Food and Drug Administration (FDA) published in March of 2022 pertaining to ophthalmic drugs and devices, titled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. 2] On April 16, 2021, the U.S.
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Article Periodic Thank You European Commission unveils proposed ban on bisphenol A in food packaging
Agency IQ
FEBRUARY 15, 2024
European Commission unveils proposed ban on bisphenol A in food packaging The European Commission has proposed a total ban on bisphenol A and related substances for use in food contact materials. B1) BPA’s regulation across so many sectors affecting different parts of the supply chain (i.e., eye damage, cat.
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FDA Issues Long-Awaited QMSR Final Rule
FDA Law Blog: Biosimilars
FEBRUARY 21, 2024
By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3
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Article Periodic Thank You What we expect EU chemical regulators to do in May 2024
Agency IQ
MAY 3, 2024
What we expect EU chemical regulators to do in May 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. On May 29-30, the agency will host ECHA IT Days , a two-day conference held in Helsinki, Finland dedicated to all things related to information technology and chemical regulations.
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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?
FDA Law Blog: Drug Discovery
DECEMBER 7, 2022
Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
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Analysis Chemical Thank You What we expect EU chemical regulators to do in August 2024
Agency IQ
AUGUST 2, 2024
What we expect EU chemical regulators to do in August 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Other consultations ending in August include two addressing potential candidates for substitution and exemption conditions under the Biocidal Products Regulation (BPR), including for the substance DBNPA.
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eMDR System Enhancements
FDA Law Blog: Biosimilars
MARCH 8, 2023
By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023.
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Article EMA Thank You What we expect European regulators to do in August and September 2024
Agency IQ
AUGUST 2, 2024
What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.
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Analysis Chemical Thank You What we expect EU chemical regulators to do in September 2024
Agency IQ
AUGUST 30, 2024
What we expect EU chemical regulators to do in September 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. A full list of chemical events is also scheduled for September, as regulators and regulatory affairs professionals return to work after the summer holidays.
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Article Periodic Thank You What we expect EU regulators to do in November 2023
Agency IQ
OCTOBER 27, 2023
What we expect EU regulators to do in November 2023 Welcome to AgencyIQ’s roundup of upcoming regulatory activities in the EU chemicals sector. Regulation on detergents and surfactants The expert working group on detergents is scheduled to hold a meeting on November 17.
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FDA Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States
The Pharma Data
FEBRUARY 19, 2022
Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. This alert covers FDA-regulated products purchased from Family Dollar stores in those six states from Jan. Today, the U.S. We will continue to work to protect consumers.”. 1, 2021, through the present. 29 and Sep.
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Article Periodic Thank You What we expect EU chemical regulators to do in June 2024
Agency IQ
MAY 31, 2024
What we expect EU chemical regulators to do in June 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Another consultation is closing this month on a draft implementing regulation that is amending the label format for fluorinated greenhouse gases (F-gases) under the new F-gas Regulation (EU) 2024/573.
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Article Periodic Thank You What we expect EU regulators to do in December 2023
Agency IQ
DECEMBER 1, 2023
What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Highlights of chemical regulatory activities Consultations open under the REACH and CLP regulations are coming to an end in December. Events happening next month include two ECHA meetings (i.e.,
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Article Periodic Thank You What we expect EU regulators to do in March 2024
Agency IQ
MARCH 1, 2024
What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA consultations under the CLP Regulation closing in March CLP: Harmonized classification and labeling (CLH) Consultations on classification and labeling harmonization (CLH) are open for 60 days.
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Article Periodic Thank You What we expect EU regulators to do in January 2024
Agency IQ
JANUARY 4, 2024
What we expect EU regulators to do in January 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. The Commission may be close to delivering this proposal , given that the EU executive recently adopted a package of related draft legislation in support of the CSS’s one substance-one assessment (1S1A) ambition.
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Article EMA Thank You Commission proposes guidelines to flesh out the newly finalized Variations Regulation
Agency IQ
JUNE 21, 2024
Commission proposes guidelines to flesh out the newly finalized Variations Regulation This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.
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Regulatory Developments in Ophthalmology: Applying New FDA Guidance, Part Two
The Premier Consulting Blog
MAY 11, 2023
In this second of our two-part series, we continue our discussion about significant recent developments regarding the regulation of ophthalmic products and discuss what to expect in the months ahead. In March of 2022, the agency issued a guidance document titled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4.
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Article Periodic Thank You What we expect EU regulators to do in February 2024
Agency IQ
FEBRUARY 2, 2024
What we expect EU regulators to do in February 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. BY SCOTT STEPHENS, MPA | JAN 26, 2024 10:22 PM CST Highlights of upcoming chemical regulatory activities Consultations under the REACH and CLP regulations are coming to an end in February.
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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on
Agency IQ
JUNE 16, 2023
The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.
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Transitioning to eCTD v4.0
The Premier Consulting Blog
APRIL 27, 2023
Starting in 2016, many versions were developed through internal collaboration and change requests until, in 2022, eCTD v4.0 Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5 Implementation Package v1.5 Module 1 Implementation Package FDA eCTD v4.0
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52 Analysis Life Sciences Thank You Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement
Agency IQ
AUGUST 25, 2023
Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so.
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40 Article EMA Thank You EMA publishes first electronic Product Information as pilot progresses
Agency IQ
NOVEMBER 20, 2023
EMA publishes first electronic Product Information as pilot progresses In 2022, the European Commission, Heads of Medicines Agencies and EMA established a common standard for electronic Product Information, or ePI, an electronic representation of information patients usually receive in paper format along with their medicines.
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Commercial interests contribute to drug use and addiction
National Institute on Drug Abuse: Nora's Blog
SEPTEMBER 25, 2024
Great progress has been made in reducing smoking in the United States, which has led to major improvements in health, but the rapidly growing vaping industry, if not properly regulated, could jeopardize this. Published online July 15, 2022. Prevalence of Problem Gambling: A Meta-analysis of Recent Empirical Research (2016–2022).
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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach
FDA Law Blog: Biosimilars
JULY 10, 2023
Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Philip Won & Adrienne R.
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Article FDA Thank You FDA finalizes guidance on electronic submissions for OTC products
Agency IQ
JULY 26, 2024
BY AMANDA CONTI | JUL 24, 2024 9:57 PM CDT Background: Modernizing regulation of over-the-counter (OTC) products Nonprescription products, also called over-the-counter (OTC) products, must demonstrate the ability to be used safely and effectively without the supervision of a qualified healthcare professional.
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AI-designed protein awakens silenced genes, one by one
The Pharma Data
MARCH 7, 2022
The new technique controls gene activity without altering the DNA sequence of the genome by targeting chemical modifications that help package genes in our chromosomes and regulate their activity. The chemical modifications that regulate gene activity are called epigenetic markers. 2022 Mar 1;38(9):110457. 2022.110457.
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Successful Applications of Real-World Data and Real-World Evidence in Rare Disease Programs
The Premier Consulting Blog
OCTOBER 11, 2022
During that meeting, the sponsor presented data by endpoint, which complemented the data package and indicated the benefits of treatment outweighed the risks. Presentation, European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) 2022. The FDA also granted a second meeting for review.
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The Economics of Investigational Device Exemption (IDE) Studies: What You Need to Know About Medicare Coverage
The Premier Consulting Blog
DECEMBER 28, 2023
This article reviews the regulations governing charging or obtaining insurance coverage for an investigational device. CMS has created a checklist to assist sponsors in submitting a complete package. 2] Code of Federal Regulations. 3] Code of Federal Regulations. Resources [1] US Food and Drug Administration.
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Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases
Agency IQ
JULY 8, 2024
In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. It also proposed several packaging changes to safeguard against misidentification. The Medical Gas Safety Act , introduced by Rep.
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Analysis Chemical Thank You Spurred by NRDC report, California senator proposes state ban on PFAS
Agency IQ
FEBRUARY 23, 2024
Background: PFAS regulation in California PFAS have been the subject of significant regulations in California, beginning in the 2010s [for an in-depth review of PFAS regulation in California, see the AgencyIQ analysis here ]. In 2019, the state began to significantly ramp up its PFAS regulation and research.
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Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines
Agency IQ
JULY 12, 2024
Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. active pharmaceutical ingredient, fill/finish, packaging/labeling). points of disruption).
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Analysis Chemical Thank You What’s going on in the world of PFAS – early 2024 edition
Agency IQ
FEBRUARY 12, 2024
What’s going on in the world of PFAS – early 2024 edition This feature from AgencyIQ focuses on the wide world of per- and polyfluoroalkyl substance regulation, legislation, and litigation around the United States. The length of the carbon chain has traditionally been a factor in how PFAS are regulated or targeted. since June 21, 2006.
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Article Periodic Thank You E.U. chemical developments we’re expecting in October 2023
Agency IQ
SEPTEMBER 29, 2023
The Commission has prepared a draft implementing regulation for the active substance that is expected to be presented for a final vote at PAFF’s upcoming meeting. Proposal for a regulation Initiative entry Chemicals – making best use of E.U. Proposal for a regulation Initiative entry E.U. CLP revision.
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Health Highlights, Nov. 4, 2020
The Pharma Data
NOVEMBER 4, 2020
After voters approve the measures, the state legislatures usually will need to set up regulations in each state. The affected product is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. Right now, 11 states have fully legalized marijuana, CNN noted. In New Jersey, medical use already is legal.
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Analysis Chemical Thank You FDA delays enforcement of cosmetic product listing and facility registration, issues finalized guidance
Agency IQ
NOVEMBER 10, 2023
NOV 8, 2023 10:02 PM CST Regulatory background The Federal Food, Drug, and Cosmetics Act (FD&C Act) is administered by the Food and Drug Administration (FDA) and regulates cosmetics. . | BY PATRICIA ISCARO, ESQ. | Beauty shops, salons, retailers, hospitals, and physicians’ offices, among others, are not considered “facilities.”
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Analysis Chemical Thank You FDA updates list of chemicals in the food supply under agency review
Agency IQ
MARCH 7, 2024
BY WALKER LIVINGSTON, ESQ | MAR 5, 2024 6:33 PM CST Background: Food chemical safety at the FDA The FDA has primary authority over the chemicals used in food, including those used as food additives, colorants, in food packaging and more. A former EPA assistant administrator, Jones has focused much of his career on chemical regulation.
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Analysis Chemical Thank You What’s going on in the world of PFAS – Q3 Edition
Agency IQ
JULY 28, 2023
In the Fall 2022 Unified Agenda , the rule was planned for an August 2023 release date, however in the recently released Spring 2023 Unified Agenda, the planned release date has been moved to February 2024. The proposed NPDWR, released on March 29, 2023 , is likely receiving the “fast track” treatment.
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Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)
The Pharma Data
MAY 2, 2022
The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function.
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Article EMA Thank You The devil is in the details: a deep dive into the state of Notified Body designations
Agency IQ
JUNE 7, 2024
The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.
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