FDA says no ‘clear relationship’ between GLP-1 drugs and suicide risk
BioPharma Drive: Drug Pricing
JANUARY 12, 2024
Regulators will continue to evaluate suicide ideation as the data don't "definitively rule out" an association.
How AI will reshape pharma by 2025
Drug Target Review
DECEMBER 20, 2024
” Weve definitely come across people in the pharma industry who worry that AI means companies might steal our data or use it in harmful ways. Smith states, weve definitely come across people in the pharma industry who worry that AI means companies might steal our data or use it in harmful ways.
Clinical Trials 
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FDA holds the line on remanufacturing definitions in newly finalized guidance
Agency IQ
MAY 10, 2024
The new guidance maintains the agency’s existing definitions of remanufacturing and servicing, but adds a new section that provide a high level overview of the medical device regulations – primarily for those “less familiar.”
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CMS Definition of “New Formulation” Upheld in Federal Court
FDA Law Blog: Biosimilars
APRIL 3, 2023
Kirschenbaum — On March 31, the Federal District Court for the District of Maryland upheld CMS’s definition of a “new formulation” under the Medicaid Drug Rebate Program (MDRP). Examples in the regulation include extended-release formulations, new strengths, dosage forms, routes of administration, ingredients, and combinations.
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The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”
FDA Law Blog: Biosimilars
APRIL 16, 2024
Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).
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EPA releases final PFAS drinking water regulations – with five-year compliance timeline
Agency IQ
APRIL 12, 2024
BY WALKER LIVINGSTON, ESQ The EPA has released its much-awaited National Primary Drinking Water Regulation for six different PFAS. There are a wide variety of definitions for PFAS and consistent debate on which definition is most applicable. Fill out the form to read the full article.
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Risk Management Data Strategy – Insights from an Inquisitive Overseer
Perficient: Drug Development
AUGUST 19, 2024
Traditional risk managers, by their job definition, are highly cautious of the result sets provided by the analytics teams. Banks have silos, these silos have been created due to mergers, regulations, entities, risk types, chinese walls, data protection, land laws or sometimes just technological challenges over time.
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7 Steps to Define a Data Governance Structure for a Mid-Sized Bank (Without Losing Your Mind)
Perficient: Drug Development
MARCH 25, 2025
Establish a single source of truth Create a glossary that doesn’t read like a legal document Accept that these definitions will change more often than a teenager’s social media profile It’s not perfect, but it’s governance, not a philosophical treatise on the nature of reality. So very, very wrong.
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Stop the Presses! DEA and DOJ Fine eBay for not Reporting Sales of Tableting and Pill Press Machines
FDA Law Blog: Biosimilars
FEBRUARY 7, 2024
The CSA and regulations promulgated by DEA regulate the sale, import, and export of tableting machines the same as they regulate List I chemicals. The regulations also require detailed information about each transaction involving a tableting machine, including the date, name and address, quantity, method of transfer, etc.
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The Active Ingredient Stands Alone
FDA Law Blog: Biosimilars
JULY 11, 2023
To set the stage for this case, we need to go back to March 2020 , when a new definition of “biological product” threw the world of protein products into a tizzy. As a result of the Biologics Price Competition and Innovation Act (BPCIA) passed in 2010, the definition of a “biological product” expanded to include “proteins.”
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Analysis Chemical: 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. A quick background on PFAS Per- and polyfluoroalkyl substances (PFAS) are a wide class of synthetic organic chemicals.
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Mechanism of Analgesia by Gabapentinoid Drugs: Involvement of Modulation of Synaptogenesis and Trafficking of Glutamate-Gated Ion Channels [Minireview]
ASPET
NOVEMBER 2, 2023
Gabapentinoids have clinically been used for treating epilepsy, neuropathic pain, and several other neurological disorders for >30 years, however, the definitive molecular mechanism responsible for their therapeutic actions remained uncertain.
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FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
FDA Law Blog: Biosimilars
FEBRUARY 9, 2024
Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.
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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.
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Article FDA Thank You FDA holds the line on remanufacturing definitions in newly finalized guidance
Agency IQ
MAY 10, 2024
FDA holds the line on remanufacturing definitions in newly finalized guidance Almost three years after the initial draft, the FDA has now finalized guidance describing the differences between medical device “servicing” and “remanufacturing” and each activity’s quality system implications. That draft guidance came out in 2021.
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Article Periodic Thank You The EPA has a new, enforceable definition for PFAS. What does it actually cover?
Agency IQ
OCTOBER 6, 2023
The EPA has a new, enforceable definition for PFAS. As part of its new PFAS reporting rule, the Environmental Protection Agency has published a newly enforceable definition of PFAS that significantly increases the number of chemicals covered by the definition, and therefore, the rule. What does it actually cover?
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It’s the Law Now –Cybersecurity Information in Premarket Submissions
FDA Law Blog: Biosimilars
APRIL 25, 2023
510(k), premarket approval application (PMA), Product Development Protocol (PDP), De Novo, or Humanitarian Device Exemption (HDE)] for a device that meets the definition of a cyber device under this section shall include such information as [FDA] may require to ensure that such cyber device meets the cybersecurity requirements. . . .
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Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices
FDA Law Blog: Biosimilars
MAY 6, 2024
Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. are cybersecure.
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Overcoming Orphan Drug Development Challenges with Real-World Data and Evidence
PPD
MARCH 11, 2025
While there is no universally accepted definition for rare disease, it is estimated that more than 10,000 distinct rare conditions exist, and people living with these rare diseases represent as much as 10% of the global population. In rare diseases, evidence gaps are often significant, necessitating de novo evidence generation.
FDA Releases Draft Guidance on Essential Drug Delivery Outputs
FDA Law Blog: Biosimilars
JULY 23, 2024
Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.
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Article EMA Thank You British regulators tease new device regulations in informative live session
Agency IQ
MARCH 7, 2024
British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]
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Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs
Agency IQ
JUNE 28, 2024
New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. Does this guidance offer the formal definition of “orphan device” we’ve been waiting for?
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Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents
FDA Law Blog: Biosimilars
JUNE 13, 2024
While the relevant regulation defines “drug product” as the “finished dosage form,” which theoretically includes the delivery device, the Court again falls back on the wording in 21 C.F.R. The Court addressed Teva’s valid argument that the Inhaler Patents are drug product patents and thus listable.
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Consent Management for Compliance and Customer Experience Benefits
Perficient: Drug Development
NOVEMBER 14, 2023
Data privacy has become an increasingly complex subject, especially with the introduction of the California Consumer Privacy Act (CCPA) and similar regulations emerging in other states. Non-compliance with these regulations can result in hefty fines, as seen with Sephora’s recent $1.2
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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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Analysis Chemical Thank You The 103 regulations the EPA is currently working on
Agency IQ
JULY 22, 2024
The 103 regulations the EPA is currently working on On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.
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Analysis Chemical Thank You EPA publishes amendments to PCB regulations
Agency IQ
SEPTEMBER 1, 2023
EPA publishes amendments to PCB regulations The Environmental Protection Agency has finalized a suite of regulations related to polychlorinated biphenyls, including extraction, disposal, and cleanup regulations. PCB-specific regulations are codified in the Code of Federal Regulations. a closed system) uses of PCBs.
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Article EMA Thank You U.K. regulator lays out proposal for international device and diagnostics recognition
Agency IQ
MAY 28, 2024
regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).
Analysis Chemical Thank You Updates to TSCA new chemicals regulations hit OIRA for review
Agency IQ
MAY 28, 2024
Updates to TSCA new chemicals regulations hit OIRA for review The Office of Information and Regulatory Affairs has begun review of a final rule that will change how the EPA handles new chemical reviews under the Toxic Substances Control Act (TSCA). TSCA itself has numerous subsections focused on different aspects of chemical regulation.
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Analysis Chemical: Bavaria floats resolution in Bundesrat urging “PFAS regulation with a sense of proportion”
Agency IQ
AUGUST 25, 2023
Manufactured since the 1940s, their carbon-fluorine bond tends to be the hallmark of a PFAS (though there is no common definition). This bond is one of the strongest in organic chemistry, making this family of chemicals highly effective at resisting water, oil, and heat. Fill out the form to read the full article.
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Analysis Chemical Thank You Supreme Court significantly expands time to file lawsuits over agency regulations
Agency IQ
JULY 8, 2024
Supreme Court significantly expands time to file lawsuits over agency regulations The Supreme Court has issued its opinion in Corner Post v. The Supreme Court has interpreted the definition of “final agency action” in Bennett v. 021 per transaction plus.05% 05% of the transaction’s value.
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40 Analysis Chemical Thank You Bavaria floats resolution in Bundesrat urging “PFAS regulation with a sense of proportion”
Agency IQ
AUGUST 25, 2023
Manufactured since the 1940s, their carbon-fluorine bond tends to be the hallmark of a PFAS (though there is no common definition). PFAS regulation in the E.U. Two high-profile initiatives to regulate PFAS in the E.U. are currently underway.
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Available for Preorder: The 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers
Drug Channels
FEBRUARY 22, 2022
Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. The 2022 Economic Report on U.S.
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CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program
FDA Law Blog: Biosimilars
JUNE 2, 2023
Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.
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PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer
The Pharma Data
JANUARY 24, 2021
Completion of the transaction is subject to customary closing conditions, including completion of due diligence, negotiation of definitive agreements and receipt of all necessary approvals. Persons”, as such term is defined in Regulations under the U.S.
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Mirikizumab Up-Regulates Genes Associated with Mucosal Healing in Ulcerative Colitis for Up to One Year in Phase 2 Study
The Pharma Data
JULY 11, 2021
In a previously-published Phase 2 study evaluating patients with UC, mirikizumab down-regulated several gene transcripts associated with inflamed mucosa and up-regulated gene transcripts correlated with healthy mucosa and markers of functional healing after 12 weeks, as defined by clinical disease indices of endoscopy and histology.
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Available for Preorder: The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers
Drug Channels
FEBRUARY 21, 2023
Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. The 2023 Economic Report on U.S.
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Key Elements and Implications of the Draft EU JCA Implementing Act
Cytel
MARCH 20, 2024
1 The draft is currently open for public consultation until April 2, and feedback received will be considered before the European Commission finalizes the Implementation Act.
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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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Reporting to the IRB: Investigator Noncompliance
Advarra
MARCH 5, 2024
While the regulations governing clinical research refer to “noncompliance” several times, the term is not actually defined in the regulations. A Definition of Investigator Noncompliance While no official regulatory definition is available, we wanted to provide some examples to assist the research community.
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52 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. However, a producer may also choose to apply for independent compliance with the requirements.
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DEA Regs Bulk Up with 2014 Anabolic Steroid Control Law Additions
FDA Law Blog: Biosimilars
AUGUST 4, 2023
Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). 50,036 (Aug. at 50,037 codified at 21 C.F.R.
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52 Analysis Life Sciences Thank You Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon
Agency IQ
APRIL 12, 2024
Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. In early 2023, AgencyIQ conducted a landscape analysis of DCT policy in the U.S.
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FDA Knows Its Own Strength—and It Includes Concentration
FDA Law Blog: Biosimilars
FEBRUARY 26, 2024
Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R. FDA replied that its definition of strength including concentration was clear even in 2009. FDA explained that its bioequivalence regulations at 21 C.F.R.
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