Drug Target Review

AUGUST 7, 2024

However, making informed labelling decisions during preclinical stages is complex and requires expertise in a variety of areas, including clinical pharmacology, toxicology, regulatory affairs and medical writing. Precise labelling and artwork help prevent confusion and enhance overall patient safety.

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The Premier Consulting Blog

JUNE 8, 2023

The goal is to minimize regulatory and execution risks through a well-defined clinical, clinical pharmacology, nonclinical, and CMC (chemistry, manufacturing, and controls) development plan and a time and cost analysis for market entry.

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Alta Sciences

FEBRUARY 8, 2024

Utilizing 10 state-of-the-art simulators available in-house at our Montréal clinical facility (with the capacity for more than 20), we are equipped to measure a range of studies; from impairment in cognition and comparing compounds to assessing the impact on new formulations have on impairment.

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Alta Sciences

DECEMBER 14, 2023

Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. We can manufacture almost every dosage form on the market. Image GettyImages-897885148_pharmacy.jpg Tags Clinical Trials Regulatory Excellence - Licenses for Schedule I through IV drug substances.

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The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to.

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Alta Sciences

OCTOBER 30, 2023

35: Critical Considerations for the Safe and Compliant Manufacture of Highly Potent Drugs Mainly driven by oncological research, the demand for highly potent active pharmaceutical ingredients (HPAPIs) has increased over the past 10 years—with over 25% on the market formulated with HPAPIs. Read or listen now.

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The Pharma Data

NOVEMBER 9, 2020

He is also a current member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology and the Scientific Advisory Panel on Opioid Analgesic Abuse. XPhyto Therapeutics Corp. ON BEHALF OF THE BOARD. “Hugh Rogers” Hugh Rogers, CEO and Director.

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The Pharma Data

DECEMBER 17, 2020

Ampholipad recently achieved an important milestone in its global commercialization efforts, having signed the first term sheet in Latin America, with options in other markets. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine.

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Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Agency IQ

OCTOBER 6, 2023

Amanda Conti, AgencyIQ What kind of biologic products entered the market? Under the 351(k) pathway, biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability.

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Agency IQ

DECEMBER 11, 2023

In addition, it may also be unethical to operate a control arm in some cases, such as when there is no currently marketed treatment option for a life-threatening disease. In other cases, patients may not wish to enroll in a study if there is a chance they would not benefit, as would be the case if they might receive a placebo.

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Agency IQ

JUNE 16, 2023

0910-AH55 December 2023 September 2023 Proposed Rule Clinical Holds in Medical Device Investigations The proposed rule would create procedures for suspending, i.e., imposing a hold (a “clinical hold”) on, a clinical investigation of a medical device. the drug and device) of the combination product.

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Agency IQ

FEBRUARY 12, 2024

A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice. Other guidances of note include one on the “study of sex differences in the clinical evaluation of medical products.”

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Alta Sciences

MAY 15, 2023

TOP 5 WAYS INTEGRATED DRUG DEVELOPMENT SOLUTIONS SAVE YOU TIME AND MONEY aasimakopoulos Mon, 05/15/2023 - 16:06 Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 billion , without, for the most part, shorter development timelines.

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Alta Sciences

JULY 31, 2024

These are just some examples that highlight the critical importance of diversity in clinical trial data for the medicines reaching the market. Up to 75% of Pacific Islanders , for instance, cannot metabolize the antiplatelet drug clopidogrel into its active form, increasing their risk of adverse outcomes after angioplasty.

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Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

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Agency IQ

JULY 28, 2023

For example, a letter from Massachusetts Senator Ed Markey called on FDA to “enhance post-market surveillance of opioids, including by conducting regular, formal reviews of opioid approvals,” among other regulatory activities. Read AgencyIQ’s backgrounder on the FDA’s recent responses to the opioid crisis here. ].

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Agency IQ

OCTOBER 27, 2023

the drug and device) of the combination product.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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The Pharma Data

OCTOBER 15, 2020

marketing and diagnostics. Trevi Therapeutics – Shashank Rohatagi was named vice president of Pharmacology and Clinical Phrarmacokinetics. Shashank joins Trevi from Metrum Research Group where he was senior principal scientist for Clinical Pharmacology. At Spark, he served as head of U.S. Katherine S.

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Agency IQ

FEBRUARY 15, 2024

Priority A List. The guidance will provide a comprehensive, systematic and stepwise approach with examples, when applicable, to illustrate how to make this determination. The guidance will cover best practices for information submission and other communications.

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Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

FEBRUARY 2, 2024

Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)

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Agency IQ

DECEMBER 1, 2023

The final rule takes into account the recommendations of the Blood Products Advisory Committee, serving as a device classification panel, regarding the classification of these devices. the drug and device) of the combination product.

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Agency IQ

MARCH 1, 2024

Start Date End Date Event Event Type Center 02/26/2024 02/26/2024 FDA/CDER and American Association of Pharmaceutical Scientists (AAPS) Hybrid Public Workshop Public CDER 02/27/2024 02/27/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer, Black History Month Program: “Real Talk: Our Stories as Black Oncologists at the FDA” Webcast (..)

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The Pharma Data

FEBRUARY 8, 2021

Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions due to Mineralocorticoid Excess – ZYTIGA ® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1)].

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Alta Sciences

MARCH 27, 2025

We are thrilled to introduce our 2025 CDMO Leadership Awards winners to the Outsourcing community, and honored to offer such an important tool for drug sponsors in selecting their best-fit partner to help bring life-saving therapies to market, says Louis Garguilo, Chief Editor at Outsourced Pharma.

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FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

will often not elapse for all subjects who received an investigational [gene therapy] product in the pre-marketing program before the product is licensed. Considering that, the safety data generated during clinical trials may not capture all possible delayed adverse events.”

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Conversations in Drug Development Trends

JANUARY 6, 2025

Similarly, the EMAs PRIority MEdicine (PRIME) designation and conditional marketing authorization enable accelerated approval for drugs addressing critical and underserved medical needs, provided they meet stringent evidence requirements.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. Such meetings should also be multi-disciplinary, not discipline-specific.

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Drug Target Review

NOVEMBER 27, 2024

The global biomarker discovery outsourcing service market was estimated at $2.7 Clinical Pharmacology & Therapeutics. Outsourcing Biomarkers in Clinical Trials: Advantages and Disadvantages. billion in 2016 and continues to grow. Available from: [link] Bakker E, Hendrikse NM, Ehmann F, et al. 2022 Mar 5;112(1):69–80.

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New Drug Approvals

APRIL 21, 2025

10] In December 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Beyonttra, intended for the treatment of transthyretin amyloidosis in adults with cardiomyopathy. [2] 26 November 2024. .

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Agency IQ

JULY 12, 2024

Proposed Rule Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition December 2024 This proposed rule, if finalized, would allow a specific ingredient to be marketed in or as a dietary supplement. and the E.C.

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