Drug Channels

JULY 21, 2025

Join 700 annual attendees and nearly 100 expert speakers to master complex regulatory guidelines to deliver compliant government pricing and reporting programs. Fireside Chats where an expert panel of attorneys discuss the most pressing issues facing MDRP and Government Pricing.

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Advarra

MARCH 6, 2025

Over the years, Advarra has reviewed a wide range of clinical research studies and worked every day alongside leading pharmaceutical manufacturers, medical researchers, and healthcare institutions. Advarra draws members from leading academic institutions, government agencies, and clinical research organizations.

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Codon

JULY 17, 2025

government could do until the 1938 Federal Food, Drug, and Cosmetic Act gave authority to the FDA to regulate drugs. Rivus Pharmaceuticals raised over $100m to take their DNP prodrug, HU6, into clinical trials for obesity in 2022. Still, there wasn’t much the U.S. The agency promptly used its new powers to ban DNP.

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FDA Law Blog: Biosimilars

NOVEMBER 18, 2024

Although not altogether surprising, the formality of an official announcement still came as a shock to many of us who work in areas regulated by HHS, as well as to many others in the public health arena. Wise government officials will modulate their views as they learn new facts. for Secretary of Health and Human Services (HHS).

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Drug Patent Watch

FEBRUARY 18, 2025

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs.

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FDA Law Blog: Biosimilars

JUNE 1, 2025

Senator Dick Durbin (D-IL) expressed concerns over the agencys ability to regulate direct-to-consumer (DTC) prescription drug advertisements following recent workforce reductions. stating that he would advise President Trump to ban pharmaceutical advertising on TV. Martin Makary, U.S. Kennedy Jr., In 2021, the U.S.

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FDA Law Blog: Biosimilars

JULY 13, 2025

Fiscal Discipline & Deregulation Framed as a strategy to enhance fiscal accountability, the initiative is part of the administration’s purported broader goals to control taxpayer spending, streamline government, and reverse the last administration’s federal job growth.

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DrugBank

OCTOBER 4, 2024

Deal Structuring Deal structuring in pharmaceutical M&A requires a balance of financial, legal, and strategic considerations. However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks.

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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

Karst — If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda Pharmaceuticals, Inc. VANDA PHARMACEUTICALS, INC. VANDA PHARMACEUTICALS, INC. 24-270 VANDA PHARMACEUTICALS, INC.

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thought leadership

APRIL 4, 2025

The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy. Pharmaceutical tariffs of 25% have been forecasted causing many global organizations to investigate the consequences of the tariffs on their overall product portfolio.

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The Pharma Data

AUGUST 31, 2020

Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. MONTRÉAL, QC – August 31, 2020 – Janssen Inc.,

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DrugBank

APRIL 25, 2024

As the pharmaceutical industry is pushing to deliver new and better drugs while racing against time and budget constraints, it is becoming crucial to not just use artificial intelligence (AI) but truly maximize its potential. Invest in Your Tech Infrastructure A solid tech foundation is essential for AI to work in the pharmaceutical sector.

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Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. These risks face fewer regulations but must meet certain standards to ensure ethical use.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Federal Court Orders Puerto Rico Pharmaceutical Distributor to Pay $12 Million in Connection with Alleged Failure to Report Suspicious Orders of Pharmaceutical Drugs and Other Controlled Substance Violations, Nov. The government asserted additional allegations that are outside our scope. 6, 2023 ( DOJ Press Release ).

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The Pharma Data

AUGUST 5, 2020

Government for 100 Million Doses of Investigational COVID-19 Vaccine. Government for 100 Million Doses of Investigational COVID-19 Vaccine. Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. government may also purchase an additional 200 million doses of Ad26.COV2.S

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Pharmaceutical Development Group

AUGUST 9, 2021

Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. There are different tests to assess the quality of a pharmaceutical product.

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The Pharma Data

DECEMBER 10, 2020

Pharmaceutical Care Management Association , the Court recognized that state legislatures have important powers to regulate abuses of corporate healthcare middlemen, called Pharmacy Benefit Managers (PBMs). In Rutledge v. Attorneys general from 45 states filed briefs opposing the PBM industry.

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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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Drug Channels

JULY 18, 2022

You'll return to the office having mastered complex regulatory guidelines to deliver compliant government pricing and reporting programs. Don’t miss the Medicaid Drug Rebate Program Summit coming up this fall in Chicago (or virtually). And so much more !

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The Pharma Data

AUGUST 5, 2020

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. 5, 2020 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) (the Company) today announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. NEW BRUNSWICK, N.J., Follow us at @JNJNews.

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biobide

MAY 18, 2023

Good laboratory practice (GLP) ensures the safety, quality, and organization of pharmaceutical research. The practice is followed to maintain consistently high standards and comply with any regulations set by government agencies, internal company procedures, and international regulations, like the 3Rs.

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ACTO

DECEMBER 17, 2024

The stakes for AI adoption in the pharmaceutical industry have never been higher. Yet, the critical question remains: How can pharmaceutical companies ensure responsible and compliant AI implementation while maximizing its potential for field teams? This approach provides better control over data access and security.

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

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Agency IQ

NOVEMBER 10, 2023

The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers. There are other fee-related regulations as well.

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FDA Law Blog: Drug Discovery

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. His presentation will focus on “MoCRA is Here – Now What? We can offer our readers a special discount for the event.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

Walsh, with over 26 years of experience in providing counsel to the pharmaceutical and medical device industries, will provide invaluable insights into global advertising and promotion regulations. Walsh’s unique perspectives on navigating the challenges and opportunities presented by advertising and promotion regulations worldwide.

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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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The Pharma Data

SEPTEMBER 28, 2020

UK and EU pharmaceutical industry bodies ABPI and EFPIA have joined forces to ask the UK government and the European Commission to prioritise medicines in upcoming trade talks. Pharma industry bodies call for medicine supply to be safeguarded in upcoming talks.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Walsh among an elite panel discussing “Around the World Hot Topics” – a session dedicated to exploring recent enforcement trends, regulator expectations, and best practices in white-collar crime law. With over 26 years of dedicated service to the pharmaceutical and medical device industries, Ms. More notably, Ms.

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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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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. has a strong voice in the world. citizens; 2.

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H1 Blog

NOVEMBER 15, 2023

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game.

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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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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The Pharma Data

JANUARY 24, 2021

About Citius Pharmaceuticals, Inc. Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. SOURCE Citius Pharmaceuticals, Inc. CRANFORD, N.J. ,

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FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years.

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The Pharma Data

JANUARY 13, 2021

“Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: [link]. Source link.

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