FDA Law Blog: Drug Discovery

MARCH 6, 2024

Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY. Prior to HP&M, John served 15 years at the Department of Justice, serving most recently as the Assistant Director of the Consumer Protection Branch, where he led the Corporate Compliance and Policy Unit.

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FDA Compliance Pharmaceuticals Pharmaceutical Companies 59

H1 Blog

JULY 30, 2024

This effort seeks to provide the pharmaceutical industry with more accurate representation of patient populations, thereby enhancing the safety and efficacy for prescription drugs and medical devices. Hence, pharmaceutical companies need to start making preparations to ensure compliance with the new requirements.

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FDA Clinical Trials Compliance Pharma Companies 59

Drug Target Review

AUGUST 9, 2024

What is drug formulation? Drug formulation is the process of designing and producing a final medicinal product from an active pharmaceutical ingredient (API). 1 The goal is to create a dosage form that delivers the drug effectively to the intended site of action with optimal patient benefit and a good commercial value.

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Science Drugs Compliance Drug Development 59

PPD

OCTOBER 18, 2023

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. 1 With this growth comes increased demands for laboratory services at all steps across the development process.

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Laboratories Assay Development Small Molecule Drug Development 52

Advarra

AUGUST 21, 2024

Nowhere is this more painful than in clinical trials, the backbone of drug development. These complex studies typically generate hundreds or thousands of documents to share across clinical trial sites, pharmaceutical sponsors, physicians, patients, and regulators. However, it is often unengaging, cumbersome, and manual.

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Clinical Trials Trials Compliance Clinical Research 52

Alta Sciences

OCTOBER 28, 2024

This comprehensive white paper provides an in-depth look at genome sequencing, proteomics, and functional characterization of the Sinclair Nanopig™, offering key insights for pharmaceutical and biopharmaceutical safety evaluations. Issue 41 of The Altascientist focuses on bioanalytical testing for immunomodulatory drugs.

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Science Clinical Trials Trials FDA 52

The Pharma Data

NOVEMBER 24, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

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FDA Drug Development Compliance Drugs 52

PPD

JULY 20, 2023

In clinical research, the role of drug packaging systems cannot be overlooked. Industry guidelines require biopharmaceutical and biotechnology companies to test their pharmaceutical packaging systems, as the systems often experience prolonged and intimate contact with drug products, drug substances and intermediates.

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Packaging Laboratories Pharmaceutical Companies Compliance 52

Alta Sciences

DECEMBER 13, 2023

Get Improved Bioavailability and Stability With This Dosage Form blussier Wed, 12/13/2023 - 22:36 HTML The choice of dosage form in drug development depends on various factors, such as the properties of the API, the therapeutic goals, and regulatory considerations.

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Clinical Trials Compliance Drug Development Trials 40

Alta Sciences

OCTOBER 5, 2023

He brings to Altasciences over a decade of experience in management and supervisory roles for manufacturing operations and supply chains, having demonstrated an impeccable standard in ensuring adherence to compliance and cGMP policies.

Clinical Pharmacology 52

Clinical Pharmacology Compliance Drug Development Pharmaceuticals 52

Fierce BioTech

JANUARY 12, 2024

Developing and Manufacturing Minitablets to Extend Drug Lifecycle pesurya Fri, 01/12/2024 - 12:38 Wed, 02/28/2024 - 11:00 Resource Type Webinar Robert Strickley, PhD Valjon Demiri, MSc Duration 60 Minutes Oral minitablets can offer several advantages in pharmaceutical applications, making them a valuable option in drug delivery.

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Drugs Packaging Compliance Drug Development 52

Vial

FEBRUARY 15, 2024

Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. Rising costs : The rising costs of clinical trials, including expenses associated with recruiting participants, trial infrastructure, data management, and regulatory compliance, is a critical issue4,5.

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Pharma Companies Clinical Trials Compliance Trials 52

Perficient: Drug Development

OCTOBER 14, 2024

Industry-specific Attributes: Chemicals, electronics, pharmaceuticals, etc. Example: A pharmaceutical company classifies its items into active pharmaceutical ingredients (APIs), excipients, and packaging materials. Compliance and Risk Management: Certain industries require strict compliance with regulatory standards.

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Packaging Compliance Production Pharmaceuticals 52

Advarra

APRIL 4, 2024

In the realm of pharmaceutical development, ensuring the safety and efficacy of new treatments is paramount. Traditionally, pharmaceutical sponsors have formed a new DSMB for each individual trial. Cost Savings Forming a new DSMB for each individual trial demands time and resources.

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Clinical Trials Pharmaceutical Companies Trials FDA 52

Pharmaceutical Development Group

FEBRUARY 1, 2022

Effective and consistent compilation of NME & NCE Product and Process Development for inclusion in the electronic submission can reduce costs and timelines. Spanogle, Ph.D. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, EU-MDR, QMS, PMS, CSV/CSA, and R&D experience.

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FDA Drug Development Science Pharmaceuticals 52

Fierce BioTech

JULY 27, 2023

Process Chemistry Unleashed: A 'Fit-for-Purpose' Approach to Accelerate IND Filing pesurya Thu, 07/27/2023 - 11:27 Tue, 09/05/2023 - 10:00 Resource Type Webinar Qixuan Lu Duration 60 Minutes Process chemistry plays a pivotal role in various stages of the pharmaceutical R&D cycle.

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Process Chemistry Compliance FDA Drug Development 52

The Connected Lab

MAY 31, 2022

Digital transformation is revolutionizing pharmaceutical research and manufacturing. Now, pharmaceutical industry stakeholders, including technology vendors, are taking the lead to facilitate change. The vast majority of pharmaceutical workflows utilize instruments and digital technologies from multiple vendors.

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Laboratory Informatics Laboratories Compliance Pharmaceuticals 52

Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

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Clinical Trials Trials Clinical Research Compliance 52

Perficient: Drug Development

AUGUST 20, 2024

Industry-specific Attributes: Chemicals, electronics, pharmaceuticals, etc. Compliance and Regulatory Adherence: Certain industries require strict compliance with regulatory standards. Usage: Consumables, repairable items, capital goods, etc.

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Compliance Production Pharmaceutical Companies Pharmaceuticals 52

The Premier Consulting Blog

NOVEMBER 20, 2024

Process validation is a critical regulatory requirement in pharmaceutical manufacturing. Key considerations for concurrent process validation In cases where expediting the drug approval process is in the public’s best interest, the PPQ may be performed concurrently with commercial manufacturing.

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Small Molecule Drugs FDA Production 52

Pharmaceutical Development Group

JANUARY 7, 2022

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. The seamless use of Data Standards also require compliance with Data Integrity Standards. Spanogle, Ph.D.

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FDA FDA Approval Biosimilars Regulations 52

Alta Sciences

MARCH 8, 2024

Inside the Altascientist: Considerations for Safe and Compliant HPAPI Manufacturing pmjackson Fri, 03/08/2024 - 19:35 In recent years, advancements in oncological research have fueled a surge in demand for highly potent active pharmaceutical ingredients ( HPAPIs ). So much so that the HPAPI market is estimated to reach USD 31.5

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Compliance Engineering Regulations Drug Development 52

PPD

JUNE 29, 2023

Although several corticosteroid treatments are available as first-line treatments, drug developers continue to seek more effective therapies to improve the wellbeing of those diagnosed with atopic dermatitis. But developing treatments for atopic dermatitis is complex and competitive.

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Clinical Trials Trials Drug Development Clinical Research 52

Vial

MAY 20, 2024

Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. The two broadest categories of drug development can be separated into the preclinical and clinical research stages. over this period.

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Clinical Research Clinical Trials Research Trials 52

The Premier Consulting Blog

NOVEMBER 12, 2023

FDA, 2023 ) These examples are not exhaustive and the potential applications of AI in pharmaceutical manufacturing may continue evolving. The number of drug submissions involving AI/ML has also increased. Developing a framework for AI/ML-based devices to ensure that these devices are safe and effective.

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FDA Drug Development Regulations FDA Approval 52

DrugBank

MAY 15, 2024

Its structure makes it incredibly difficult for drugs to bind effectively, which has stymied drug development for decades. The binding pockets on KRAS are shallow and polar , not ideal for the kinds of interactions needed for strong, effective drug binding.

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Small Molecule Molecular Biology Drugs Disease 82

Drug Target Review

MARCH 15, 2024

Transposon technologies are gaining traction due to their accuracy in integrating the gene of interest into the host genome, making them an important tool for accelerating large molecule drug development. Anis works within the strategy group in Life Sciences at Revvity, Inc.

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Engineering Molecular Biology Protein Expression Medical Schools 105

H1 Blog

SEPTEMBER 14, 2023

As pharmaceutical companies turn to CROs (Clinical Research Organizations) for trial design and technology, there are new opportunities emerging with healthcare data intelligence that can help ensure a bright future for the industry and to make trials more effective, efficient and accessible. million data points.”

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Clinical Trials Pharmaceutical Companies Trials Pharmaceuticals 59

Pharmaceutical Development Group

JANUARY 5, 2022

In December 2021, the FDA issued new guidance for Inspection of Injectable Products for Visible Particulates to improve Pharmaceutical Quality and for inclusion in the CMC. Compliance with these new focus points hinge upon proactive utilization Drug Development Services , effective FDA Pre-Submission, and comprehensive Regulatory Consulting.

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Production FDA Regulations Science 52

Alta Sciences

NOVEMBER 15, 2023

He brings over a decade of experience in management and supervisory roles, and has demonstrated an impeccable standard in ensuring compliance with cGMP policies. Get to know Angel with this Q&A: Why did you choose a profession in pharmaceutical manufacturing? In drug development, every day is a new day.

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Compliance Doctors Drug Development Regulations 40

Altus Drug Development

MAY 31, 2022

From natural health products to life-saving medicines, all pharmaceutical products must undergo an analytical method development process. Through analytical method development, validation, and transfer, drug development and manufacturing are kept safe, efficient, and compliant with the law.

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Pharmaceuticals Production Clinical Trials Drug Development 52

Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). It ensures regulatory compliance for over 15 long-term post-authorization safety studies across eight disease indications.

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Clinical Trials Clinical Research Trials Laboratories 52

The Pharma Data

APRIL 6, 2022

” Integrating Pharmaceuticals and Oncology business units. Novartis will integrate the Pharmaceuticals and Oncology business units and create two separate commercial organizations with a stronger geographic focus – Innovative Medicines US and Innovative Medicines International.

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International Pharmaceuticals Drug Development Marketing 52

Vial

MARCH 27, 2024

The Costs of Working with a CRO Running clinical trials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. However, because these trials come with a significant financial burden, sponsor companies are constantly seeking ways to optimize their operations.

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Clinical Trials Trials International Compliance 52

The Pharma Data

MARCH 20, 2021

Natural language processing (NLP) has long held potential for the life sciences field, given the industry’s reliance on text-based data in the form of clinical records, scientific papers, pharmaceutical companies’ call center transcriptions and so forth. Reed, director of life sciences at Linguamatics, an IQVIA company. “To

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Science Pharmaceutical Companies Compliance Drug Development 52

PPD

JULY 9, 2024

Companies developing new drugs and inventing new medical devices face a wide range of challenges. Most industries have in common the need to meet strict timelines while also achieving quality and compliance standards and staying within budget. However, completing this work is only half the challenge.

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Compliance Production Clinical Research Marketing 52

Agency IQ

JULY 8, 2024

The European Council held its first public debate of the proposed pharmaceutical legislation last week. There will also be a rescheduled webinar held at the end of the month to go over the Artificial Intelligence Airlock initiative spearheaded by the U.K.’s ’s Medicines and Healthcare products Regulatory Agency (MHRA).

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