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.

Regulations 109

Regulations Marketing Government Compliance 109

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.

Government 52

Government Compliance Regulations 52

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.

Regulations 116

Regulations Government Compliance Production 116

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.”

FDA 95

FDA Regulations Production Small Molecule 95

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.

Regulations 45

Regulations 45

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.

Regulations 100

Regulations Drugs 100

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.

FDA 105

FDA Compliance Regulations Engineering 105

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 45

Regulations FDA Production Government 45

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.

FDA 40

FDA Regulations Compliance Production 40

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?

Regulations 40

Regulations Government Science Production 40

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. . . .

FDA 105

FDA Regulations Production Drugs 105

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.

FDA 105

FDA Regulations Marketing Drugs 105

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.

FDA 105

FDA Drugs Pharmacokinetics Production 105

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.]

Regulations 40

Regulations International Production Government 40

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?

Trials 40

Trials Marketing Clinical Trials Disease 40

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.

FDA 116

FDA FDA Approval Production Drugs 116

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

Compliance 98

Compliance Regulations Production Marketing 98

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

FDA 59

FDA Regulations Packaging Compliance 59

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.

Regulations 40

Regulations Production Engineering International 40

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.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

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.

Regulations 40

Regulations Laboratories Production Government 40

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).

International 40

International Regulations Licensing Licensing 40

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.

Regulations 40

Regulations Government Marketing Research 40

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.

Regulations 40

Regulations Organic Chemistry Government 40

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.

Regulations 40

Regulations Government 40

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.

Regulations 40

Regulations Government Packaging Organic Chemistry 40

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.

Pharmacy 96

Pharmacy Specialty Pharmacies Biosimilars Licensing 96

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.

Drugs 59

Drugs Regulations Vaccine Government 59

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.

FDA 52

FDA Drugs Clinical Development Disease 52

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.

Regulations 52

Regulations Disease Treatment Packaging 52

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.

Pharmacy 97

Pharmacy Specialty Pharmacies Licensing Licensing 97

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.

Regulations 59

Regulations Production 59

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.

Regulations 40

Regulations Packaging Production Organic Chemistry 40

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.

Regulations 52

Regulations Clinical Research Research Government 52

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.

Regulations 40

Regulations Packaging Compliance Production 40

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.

Regulations 52

Regulations Production Drugs Clinical Trials 52

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.

Regulations 40

Regulations Trials Clinical Trials Science 40