FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. What does it mean for FDA staff?

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Perficient: Drug Development

NOVEMBER 19, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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Regulations Government Compliance Marketing 52

Drugs.com

SEPTEMBER 21, 2023

21, 2023 -- A new government report finds that federal regulators need to do more to help in the battle to keep kids and teens off tobacco. THURSDAY, Sept. Among the report’s findings were that the U.S. Food and Drug Administration needs to get.

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Perficient: Drug Development

NOVEMBER 6, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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Science Daily: Pharmacology News

JANUARY 22, 2024

They must also include all the environmental systems that regulate the functioning and state of the planet, namely all systems on Earth we all depend on, irrespective on where in the world we live. This calls for a new level of transnational cooperation, leading experts in legal, social and Earth system sciences say.

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Drugs.com

JUNE 27, 2024

THURSDAY, June 27, 2024 -- As psilocybin mushrooms become the most popular psychedelic in the United States, some states have started to ease regulations on its recreational use. Now, a new report warns that the federal government will have to.

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The Premier Consulting Blog

OCTOBER 30, 2024

With extensive experience in manufacturing techniques and regulations, the CMC services team at Premier Consulting can help sponsors navigate the development of advanced manufacturing technologies. Contact us today to find out how we can support your program.

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NIOSH Science Blog: Drugs

JULY 15, 2024

A Discussion Paper, Streamlining Regulatory Oversight of Respirators Used in Health Care Settings will Improve Worker Protection, was recently published in the National Academy of Medicine’s NAM Perspectives journal by respiratory experts outside of the federal government.

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Perficient: Drug Development

FEBRUARY 29, 2024

Providing this level of access control substantially increases the quality of governance while reducing the workload involved. Tagging can make these assets more seachable, manageable and governable. Geo-coding data with tags to comply with European regulations is also a possible target of opportunity.

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Government Regulations Compliance Marketing 78

ProRelix Research

MAY 11, 2025

Stay informed on essential regulations governing Nutraceutical Clinical Trials in India, with a detailed look at ethical standards, CDSCO oversight, and trial conduct protocols.

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Clinical Trials Regulations Trials Government 52

Drug Target Review

NOVEMBER 13, 2023

Regulating immunosuppression Beyond serving as a genetic on-off switch, Foxp3 controls greater genetic structural change within regulatory T cells, controlling chromatin architecture changes that subsequently guide the functional success of the peacekeeping immune cells.

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Government DNA RNA Regulations 104

Perficient: Drug Development

APRIL 5, 2025

Data governance helps organizations manage data appropriately.Some customers say data governance is an optional best practice but not a mandatory implementation strategy. Let’s explore why data governance is no longer optional in today’s data-driven world. Learn How Data Governance Impacts Organizations 1.

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Government Compliance Regulations Production 52

Perficient: Drug Development

OCTOBER 15, 2024

Lets talk about data governance in banking and financial services, one area I have loved working in and in various areas of it … where data isn’t just data, numbers aren’t just numbers … They’re sacred artifacts that need to be protected, documented, and, of course, regulated within an inch of their lives.

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Government Compliance Regulations Production 52

ACTO

DECEMBER 17, 2024

The Foundation: Governance and Security Successful AI implementation begins with strong platform governance and security standards. The Foundational Pillars ACTO believes in implementing four foundational pillars that will ensure responsible AI solutions that address pharmas highly regulated parameters, while providing value.

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Government Compliance Pharmaceutical Companies Pharmaceuticals 52

FDA Law Blog: Biosimilars

JANUARY 28, 2024

Gonzalez — In a new publication in the Washington Legal Foundation’s (WLF) Legal Backgrounder , we argue that FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs) is vulnerable to legal challenge, once finalized. By Jeffrey N. Gibbs & Steven J.

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Drug Patent Watch

FEBRUARY 26, 2025

However, the patentability of biologics is governed by specific laws and regulations, such as the Biologics Price Competition and Innovation Act (BPCIA). This requires a deep understanding of the science behind biologics, as well as the regulatory framework governing their development and approval.

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Drugs Government Regulations Compliance 53

Perficient: Drug Development

AUGUST 23, 2024

If you use Databricks , you probably know that Databricks Unity Catalog is the industry’s only unified and open governance solution for data and AI, built into the Databricks Data Intelligence Platform. Enhanced Query Performance Unity Catalog is well-known as a centralized metastore location in the context of governance.

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Government Compliance International Regulations 52

Common Sense for Drug Policy Blog

OCTOBER 1, 2024

New regulations governing methadone treatment for opioid use disorder go into effect in the US on October 2, 2024. As reported by the Associated Press on Sept. 20, 2024 ("US will let more people take methadone at home"):

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Perficient: Drug Development

AUGUST 15, 2024

Governance factors focus on the organization’s leadership, transparency, accountability, and adherence to ethical business practices.” ESG investing will focus resources on scrips whose underlying companies that follow positive environmental, social, and governance principles. How does it impact me?

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Agency IQ

NOVEMBER 10, 2023

The European Commission has proposed a regulation to revise the fees regulation governing the cost of compensating the European Medicines Agency (EMA) for its regulatory activities, with the aim of streamlining the fee structure and increasing fees in line with the cost of services and inflation.

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Drug Target Review

NOVEMBER 3, 2023

They identified ZNF800 as a key regulator of the differentiation of a specific gut cell type, the enteroendocrine cells. These hormones regulate digestive processes, like nutrient absorption, appetite, and glucose metabolism. This is like switching the ‘traffic lights’ on or off.”

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FDA Law Blog: Biosimilars

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. HPM is keeping a watchful eye on the various indirect means by which FDA may try to regulate LDTs.

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Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. BY LAURA DIANGELO, MPH With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. If a compliance or quality program exists only as bargaining chip to use with regulators, thats not a formula to instill good habits.

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers. How regulators will interpret and enforce its provisions may not become clear for some time.

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Clinical Trials Trials Clinical Research Government 88

biobide

SEPTEMBER 15, 2023

Given the potential harm that chemical pesticides may cause, they are naturally subject to strict regulation. These regulations have a major impact on the agricultural industry , in many cases limiting crop production and reducing income for farmers. In 2021, the UK government introduced new “Maximum Residue Levels”.

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Agency IQ

SEPTEMBER 15, 2023

For first time, FDA releases OTC drug user fees prior to start of government fiscal year The FDA today unexpectedly unveiled certain user fees under its OTC Monograph User Fee Program (OMUFA), its nonprescription drug funding and performance mechanism. Industry wants its products reviewed quickly, efficiently and predictably.

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FDA Law Blog: Biosimilars

MAY 4, 2025

1-BOC-Piperidone is a DEA-regulated List 1 chemical while (2-Bromethyl) benzene is on DEAs longstanding, recently updated Special Surveillance List. The government determined that the chemicals had been imported into the U.S. The government alleged that IMC Pro entered into business agreements with companies operating in China.

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Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. These risks face fewer regulations but must meet certain standards to ensure ethical use. An example of limited and minimal risk systems include AI in benign gaming apps and language generators. a synthetic control arm)?

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Clinical Research Research Clinical Trials Compliance 98

Perficient: Drug Development

MARCH 27, 2025

Data privacy regulations such as GDPR , HIPAA , and CCPA impose strict requirements on organizations handling personally identifiable information (PII) and protected health information (PHI). Ensuring compliant data deletion is a critical challenge for data engineering teams, especially in industries like healthcare, finance, and government.

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Drug Target Review

MAY 14, 2025

The challenges lie in regulated industries where governance frameworks for standard quantitative models dont necessarily apply to LLMs. The challenges lie in regulated industries where governance frameworks for standard quantitative models don’t necessarily apply to LLMs.

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Drugs Science Government Production 69

Perficient: Drug Development

AUGUST 19, 2024

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. This ascertains completeness of the critical data elements definition and hence aid data governance strategy in a wholesome way.

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Drug Patent Watch

MARCH 4, 2025

Stay up-to-date on regulatory requirements : Familiarize yourself with the latest guidelines and regulations governing pharmacovigilance. Train your team on pharmacovigilance best practices : Ensure that everyone involved in the development process understands the importance of pharmacovigilance.

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Advarra

MARCH 6, 2025

Food and Drug Administrations (FDA) regulations on good clinical practice, which are based on ethical standards outlined in frameworks such as the Belmont Report and the Declaration of Helsinki. Advarra draws members from leading academic institutions, government agencies, and clinical research organizations.

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FDA Law Blog: Biosimilars

MARCH 12, 2023

The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines. These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. Hyman, Phelps & McNamara, P.C.’s

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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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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward. The government asserted additional allegations that are outside our scope.

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