Drug Channels

OCTOBER 23, 2023

With regulation and policy changes, specifically surrounding the DCSCA, IRA and serialization, the loss of exclusivity wave, adoption of low-WAC products affecting GTN and the rise of alternative distribution models, there has never been a more important time for industry to unite. What can you expect?

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Drug Target Review

MARCH 12, 2024

Scientists from the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California San Diego have discovered thousands of bile acids. Bile acids are crucial signalling molecules that aid the regulation of the immune system and have essential metabolic functions, like controlling lipid and glucose metabolism.

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The Pharma Data

JUNE 6, 2025

Global Pharmaceutical Contract Sales Outsourcing Market to Reach $24.8 Billion by 2030: Strategic Insights, Regional Trends, and Technological Shifts Reshaping the Landscape The global pharmaceutical contract sales outsourcing (CSO) market is entering a transformative phase, with its value expected to grow from $17.3

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The Pharma Data

OCTOBER 27, 2021

GSK Consumer Healthcare today unveils a three-year programme to support the pharmacy profession with additional practical resources, mental health provisions and proposed policy changes as part of its new report Standing with Pharmacists in the Age of Self-Care.

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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. Palmer , Larry K. Houck , and Kalie E.

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Policy Prescription

MAY 28, 2021

NeedyMeds , a non-profit organization known for providing patients with help in finding pharmaceutical company-sponsored prescription assistance programs and other drug savings options, hosted a webinar about drug importation last year called “ Drug Importation: The topic everyone’s talking about.” Here’s one example and you can be the judge.

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Policy Prescription

APRIL 1, 2022

from licensed pharmacies to American patients. This epic counterfeit drug debacle had nothing to do with the personal importation of less expensive prescription drugs or foreign online pharmacies. pharmacies and wholesalers allegedly flouting the rules. Safe Chain Pharmacy Solutions. Fake DSCSA Pedigrees.

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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

JULY 29, 2021

The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution” – much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. The FDA granted approval of Semglee (insulin glargine-yfgn) to Mylan Pharmaceuticals Inc.

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Drug Channels

SEPTEMBER 29, 2020

As managing copay programs continues to be significantly more complex, it is imperative to stay on top of current trends, emerging regulations and future legislation. Exclusive Offer for Drug Channels Readers – View the complete agenda and register today – Be sure to use your exclusive promo code USAVE3 to save $300 *. It’s time to talk.

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The Pharma Data

NOVEMBER 16, 2020

“We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We

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Agency IQ

MARCH 25, 2024

This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes. An “outsourcing facility” per Section 503B is a registered location that engages in the compounding of sterile drugs but is not required to be a licensed pharmacy.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.

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The Pharma Data

NOVEMBER 9, 2020

Löbenberg is a director of XPhyto and is the founder and director of the Drug Development and Innovation Centre, Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Canada. About XPhyto Therapeutics Corp. XPhyto Therapeutics Corp. SOURCE: XPhyto Therapeutics Corp. .

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Agency IQ

JANUARY 4, 2024

For regulators, there are two primary concerns associated with impurities – that they may cause a drug substance to degrade (thereby reducing its efficacy or safety) and that the impurities (or their effects on the drug substance) may be harmful to patients. Read AgencyIQ’s analysis of the ICH guideline here ].

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Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Drug Target Review

DECEMBER 22, 2023

The regulatory science project I pursued for my first master’s degree titled, “21st Century Pharmaceutical Excipients: Consequences of a Global Supply Chain and Lack of Excipient Regulations” aimed to draw attention to the risks created by the lack of sufficient oversight of the pharmaceutical excipient supply chain.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. state pharmaceutical assistance programs). 1395w-114c(b)(4)(B)(i).

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. active pharmaceutical ingredient, fill/finish, packaging/labeling). See AgencyIQ’s analysis of EMA’s milestones.]

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The Pharma Data

MAY 7, 2021

International regulators and WHO call for wider public access to clinical data ( EMA ). EU regulator begins real-time review of GSK-Vir COVID-19 antibody drug ( Reuters ) ( Press ). After QSR Delays, ‘It’s Full-Steam Ahead With That Proposed Regulation,’ FDA’s Shuren Vows ( MedtechInsight ).

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Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

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Drug Target Review

MARCH 6, 2024

LSD1 demethylates histones which play a critical role in regulating the expression of genes that suppress differentiation and drive the proliferation and survival of several tumour types.

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Codon

FEBRUARY 13, 2024

Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop. 4 But the same barriers still exist today. .

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Alta Sciences

MAY 16, 2025

I started as a study director at Haskell Laboratory, overseeing studies for the businesses of DuPont, primarily in agrochemical and commodity chemicals, but also for the textile, pharmaceutical, and food industries. There, he supports PhD candidates and guides graduate research exploring the mechanisms of drug-induced liver toxicity.

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The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Persons”, as such term is defined in Regulations under the U.S. Toronto, Ontario–(Newsfile Corp. About PharmaDrug Inc. PharmaDrug Inc.

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Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.

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The Pharma Data

SEPTEMBER 29, 2021

Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee. “If Healthy kidneys act as the body’s filter, removing waste products from the blood.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

MAY 13, 2021

Before I show you what this breakthrough pain solution is, I want to let you in on the “dirty little secret” of the pharmaceutical industry. I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! And then got my Doctor of Pharmacy (Pharm. Please don’t blame yourself.

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Perficient: Drug Development

JANUARY 22, 2025

Welcome to our new series on Universal Design for Pharmacies! In this segment, well explore the importance of Universal Design in Pharmacies for All Disabilities. What is Universal Design in Pharmacies? Clear Signage Signage in the pharmacy should be in large print and braille to assist individuals with visual impairments.

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Drug Target Review

MARCH 13, 2025

The journey from distrust to collaboration among industry, academia and regulators will expedite integration, minimise clinical failures and enhance economic sustainability. About the authors Remco Jan Geukes Foppen , PhD, is an AI and life sciences expert specialising in the pharmaceutical sector. Lifescienceleader.com.

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FDA Law Blog: Biosimilars

MAY 13, 2025

Wasserstein We are still parsing through the May 12 Executive Order (EO), Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients and impacts this may have on the pharmaceutical industry. FDA may issue such waivers by regulation or on a case-by-case basis. Please bear with us.) FDC Act 804(j)(1), (2).

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FDA Law Blog: Biosimilars

MAY 12, 2025

It sets forth three directives: HHS shall consider facilitating direct-to-consumer purchasing programs for pharmaceutical manufacturers that sell their products to American patients at the most-favored-nation (MFN) price. by November 12), if significant progress toward MFN pricing is not made, HHS must propose a regulation to impose it.

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