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.
Government Packaging Regulations 
Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation
FDA Law Blog: Biosimilars
JUNE 12, 2023
By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.
Regulations 
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Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation
FDA Law Blog: Biosimilars
MARCH 3, 2024
This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. House of Representatives ( H.B. 7085 ) and Senate ( S.B.
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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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Analysis Chemical Thank You Bavaria floats resolution in Bundesrat urging “PFAS regulation with a sense of proportion”
Agency IQ
AUGUST 25, 2023
As such, they can be found in myriad applications ranging from raincoats, refrigerants, and lubricants to non-stick pans, food packaging, and semiconductors. PFAS regulation in the E.U. Two high-profile initiatives to regulate PFAS in the E.U. are currently underway. years for all consumer products covered by the ban.
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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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Article Periodic Thank You Swiss regulators align with EU on chemicals, biocides
Agency IQ
JUNE 17, 2024
Swiss regulators align with EU on chemicals, biocides The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation.
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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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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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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 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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40 Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)
Agency IQ
MARCH 1, 2024
Explainer: What a government shutdown would mean for the FDA (Updated) With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1. What is a government shut down? If none of the 12 bills are completed, then all government operations shut down.
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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 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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Best CDMO Practices for Startups: Navigating the Complex World of Contract Development and Manufacturing
Drug Patent Watch
JANUARY 9, 2025
Take the time to clearly define your technical needs, from drug substance manufacturing to packaging requirements. A: First, try to address issues through open communication and your established governance structure. Q: How can I ensure my CDMO is staying compliant with evolving regulations?
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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 New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.
Agency IQ
AUGUST 4, 2023
government to ensure that, in the wake of Brexit, Northern Ireland continues to receive critical supplies such as food and medicines. government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. Great Britain, and the E.U. member states. and the U.K.
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Article Periodic Thank You EPA grants petition on PFAS in fluorinated containers
Agency IQ
JULY 12, 2024
EPA grants petition on PFAS in fluorinated containers Following a loss at the Fifth Circuit, the EPA has a new plan to regulate PFAS in fluorinated plastic containers: traditional Toxic Substances Control Act Section 6 rulemaking. On December 8, 2023, Inhance petitioned the Fifth Circuit Court of Appeals over the orders from the EPA.
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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 EMA Thank You The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation
Agency IQ
APRIL 12, 2024
The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Directive 2001/83/EC and Regulation (EC) No 726/2004.
Analysis Chemical Thank You How states are looking to control PFAS through different legislative models
Agency IQ
MAY 10, 2024
Recently introduced legislation North Carolina: On May 1, 2024, North Carolina State Representative JOHN AUTRY introduced HB 973 , a bill to ban intentionally added PFAS in food packaging. If passed, the law would go into effect in January 2025.
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Nine Key Takeaways from Dreamforce 2023
Perficient: Drug Development
SEPTEMBER 19, 2023
Ultimately, this will reduce the cost and complexity of moving and copying data while keeping security, governance, and trust standards. Databricks Salesforce and Databricks are expanding their partnership to allow for seamless merging of data from Data Cloud with external Databricks Lakehouse Platform data.
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Article Periodic Thank You At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition
Agency IQ
MARCH 7, 2024
At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition Last week, EU chemicals regulator ECHA brought together experts from industry, government, civil society, research, and academia to discuss the future of EU chemicals regulation.
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40 Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients
Agency IQ
JUNE 7, 2024
European Commission issues EU-wide rules on pesticide ingredients The Commission has issued uniform rules governing data requirements and a work program for safeners and synergists, constituent compounds that, like active substances, must be approved for use in plant protection products in the EU.
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Article Periodic Thank You California set to ban an additional 26 chemicals from cosmetics
Agency IQ
SEPTEMBER 15, 2023
SEP 11, 2023 10:49 PM CDT Regulatory background Cosmetic ingredients in California are governed by the Federal Food, Drug & Cosmetic Act (FD&C Act), which provides that cosmetics produced or distributed for retail sale to consumers for their personal care are required to bear an ingredient declaration ( 21 CFR 701.3 ). Chapter 54.
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Welcome to SRP-RMT – Standardization Comes to Regenerative Medicine Therapies?
FDA Law Blog: Drug Discovery
NOVEMBER 2, 2023
These standards would be developed outside the Federal government, leveraging the expertise of the private sector. The standards would, as stated previously, be voluntary, unless mandated by statute or regulation, and they cannot conflict with existing law or regulation.
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Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024
Agency IQ
JULY 8, 2024
What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.
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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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Analysis Chemical Thank You Explainer: carcinogen classification in the E.U., U.S., and internationally
Agency IQ
AUGUST 18, 2023
and internationally Establishing and communicating a substance’s potential to cause cancer is a cornerstone of chemical regulation worldwide. Many entries in category 2B are only weakly associated with carcinogenicity and are generally unlikely to be regulated for causing cancer. For more on the regulation of glyphosate in the E.U.,
Lattice Unaware of Any Material Change
The Pharma Data
JANUARY 5, 2021
From donor acceptance to the final packaging and distribution of finished allografts, Lattice is committed to maintaining the highest standards of allograft quality, innovation, and customer satisfaction. This includes Certificates to Foreign Governments from the U.S. and internationally. and internationally.
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Analysis Chemical Thank You What’s going on in the world of PFAS – Q3 Edition
Agency IQ
JULY 28, 2023
The agency has kept the expected publication date for the National Primary Drinking Water Regulation (NPDWR) for six PFAS consistent between the Fall 2022 and Spring 2023 Unified Agendas [for an in-depth analysis on the proposed NPDWR, see this AgencyIQ piece ]. To contact the editor of this analysis, please email Patricia Iscaro.
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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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40 Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024
Agency IQ
AUGUST 2, 2024
What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.
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40 Analysis Chemical Thank You Regulatory roundup: EU active on PFAS as Q4 commences
Agency IQ
OCTOBER 6, 2023
France In January, the French ecology ministry published a PFAS action plan enumerating six objectives for regulating forever chemicals more comprehensively by 2027. These facilities are uniquely categorized under French law so that they may be regulated with greater oversight. agricultural activity, waste processing).
Article EMA Thank You New MDR/IVDR standardization request adds standards, moves deadlines
Agency IQ
JUNE 17, 2024
These are the lists of national and international standards the Commission plans to harmonize with its device and diagnostics regulations. But standards harmonized under the directives may not be used to show compliance with the new Medical Device Regulation, which replaced the MDD. This is similar to the situation in the U.S.,
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40 Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics
The Pharma Data
OCTOBER 14, 2020
Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration (..)
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Article FDA Thank You CDER’s latest novel drug approvals report shows how the pandemic is still affecting some drug approvals
Agency IQ
JANUARY 12, 2024
BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. Industry wants its products reviewed quickly, efficiently and predictably.
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MediWound Completes Enrollment Stage of its NexoBrid Phase 3 Pediatric StudyTop-line Data is Expected in the Second Half of 2021
The Pharma Data
OCTOBER 27, 2020
Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in adults population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.
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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40 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). See AgencyIQ’s analysis of EMA’s milestones.]
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40 Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023
Agency IQ
OCTOBER 27, 2023
What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Government shutdown: At present, the U.S.
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40 Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste
Agency IQ
JANUARY 26, 2024
Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.
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Article Periodic Thank You EPA orders manufacturer to stop producing PFAS and manufacturer petitions court
Agency IQ
DECEMBER 15, 2023
PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation. for uses under TSCA.
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40 Article EMA Thank You European Commission reveals action plan to address medicines shortages
Agency IQ
NOVEMBER 3, 2023
Regulation (EU) 2022/123 became applicable on March 1, 2022, with the exception of most provisions related to medical devices. The regulation expanded EMA’s mandate to monitor and mitigate shortages, as well as establish lists of critical medicines during major events that affect public health. [See wide level.
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