PPD

OCTOBER 12, 2023

Click to enlarge At several steps during CGT development and testing, sensitive, accurate and precise quantitation of CGT drug vectors is required. Food and Drug Administration (FDA). Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance.

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Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. Drug developers must consider ways to remove these barriers to enhance their ability to recruit and retain trial participants.

Trials 64

Trials Clinical Trials Therapies Drug Development 64

Agency IQ

JULY 7, 2023

What is the state of pharmaceutical quality in the U.S.? Call it murky A new report published by the FDA’s Office of Pharmaceutical Quality (OPQ) promises a look at the current “State of Pharmaceutical Quality.” Read AgencyIQ’s analysis of FDA’s QMM White Paper here.]

Pharmaceuticals 40

Pharmaceuticals Science FDA Production 40

H1 Blog

NOVEMBER 15, 2023

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. Compliance ensures that interactions between pharmaceutical companies and KOLs are transparent, fair, and free from any undue influence.

Compliance 59

Compliance Science Regulations Pharmaceutical Companies 59

PPD

DECEMBER 19, 2023

While the FSP model is growing in popularity and serves a critical role in pharmaceutical development, getting the most out of this model requires dedicated roles to drive implementation, communications and planning. Ready to fuel more efficient drug development?

International 52

International Research Drug Development Pharmaceuticals 52

The Pharma Data

NOVEMBER 20, 2020

Survey results reveal the supply chain has had significant challenges with drug shortages, limited access to critical medicines, increased production costs and heightened concerns around drug counterfeiting, diversion and theft. .

Pharma Companies 52

Pharma Companies Vaccine Drugs Pharmacy 52

The Pharma Data

JULY 28, 2021

Teva Pharmaceutical Industries Ltd. As one of the largest manufacturers of affordable generic medicines, Teva saves patients and payers around the globe billions of dollars each year in lower prescription-drug costs,” said Alex Brill, CEO of MGA. Teva saved the United States $28.8 billion in 2020, $4.2 Source link: [link].

Marketing 52

Marketing Biosimilars Pharmaceuticals Drugs 52

PPD

JULY 9, 2024

Companies developing new drugs and inventing new medical devices face a wide range of challenges. This requires an expert RA team capable of processing large volumes of routine submissions to support any changes to manufacturing, market expansion, or safety and quality reporting — for every drug or device in the company’s portfolio.

Compliance 52

Compliance Production Clinical Research Marketing 52

The Pharma Data

DECEMBER 28, 2020

Scopus is a biopharmaceutical company whose lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers. Russell has extensive leadership experience across diverse disciplines at numerous private and public biopharmaceutical, biotechnology and pharmaceutical companies. NEW YORK , Dec.

Pharmaceuticals 52

Pharmaceuticals Pharmaceutical Companies Government Therapies 52

The Pharma Data

JANUARY 7, 2021

The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs).

Production 52

Production FDA Pharmaceuticals Marketing 52

The Pharma Data

DECEMBER 17, 2020

The analysis of metals in pharmaceutical actives (API), raw material, and drug products has changed as well. Today’s technology has not only changed the way we receive information, but has continually adapted and progressed how we acquire information. ICP-MS/OES has emerged as a critical analytical platform for this analysis.

Compliance 52

Compliance Production Pharmaceuticals Drugs 52

The Pharma Data

NOVEMBER 16, 2020

To ensure the safety, quality and efficacy of a drug product prior to market roll out, it is critical life sciences companies can uphold the integrity and security of the data generated throughout an entire product’s lifecycle. For further information on how we process and monitor your personal data click here.

Science 52

Science Production Pharmaceuticals Marketing 52

FDA Law Blog: Biosimilars

JANUARY 24, 2024

We identify R&D opportunities to promote the development of innovative biomanufacturing pathways that could address supply chain bottlenecks for critical drugs, chemicals, and other materials. Louis, Missouri, APIIC convened a working group of 15 experts in an event titled “Pathway to Build Supply Chain Resilience for Critical Drugs.”

Small Molecule 67

Small Molecule Government Production Drugs 67

Agency IQ

FEBRUARY 21, 2024

In 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the “strongly recommended format” for submission of applications to the FDA. The format and organization of the CTD is outlined in the ICH M4 Guideline.

Science 40

Science Regulations International FDA 40

Drug & Device Law

JULY 31, 2023

It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. Medicis Pharmaceutical Corp. , Smith rejected plaintiff’s analogy between books and drug package inserts. Paddock Pool Construction Co. ,

Production 52

Production International Trials Government 52