FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

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Drug Target Review

JUNE 11, 2025

If it’s not mixable, the data value chain (from R&D phase to production phase) is neither interpretable or reproducible. He holds a PhD in pharmacy from the University of North Carolina at Chapel Hill, and an MBA from the Rochester Institute of Technology.

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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. percent on a dry weight basis. ”

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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. Keup has joined the firm to assist attorneys Karla L. Palmer , Larry K.

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The Pharma Data

AUGUST 17, 2020

The UK government is imposing stricter regulations on the sale of laxatives, to help prevent their misuse. People will need to be 18 or older to buy them from pharmacies and supermarkets. Getty Images. Rebecca Wojturska, who has overused the drugs in the past, welcomed the safeguards. Short-term relief.

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FDA Law Blog: Biosimilars

JANUARY 22, 2024

The tools it uses to accomplish that mission include those designed to help regulated entities that want to follow best public health practices, like guidances, public notifications, and requests for information. This is another area in which FDA works with industry to try to ensure voluntary compliance from regulated entities.

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Agency IQ

JANUARY 4, 2024

Now, the FDA has released guidance laying out the tests and regulatory submissions needed for the reformulation of products containing these ingredients. To help control impurities, the FDA requires all starting materials used in drug manufacturing and final pharmaceutical products to be evaluated for “identity, strength, quality and purity.”

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The Pharma Data

JUNE 6, 2025

As pharma companies grapple with mounting pressure from regulators, payers, and evolving market dynamics, the CSO model offers a compelling alternative to traditional, fully in-house sales forces. These markets are characterized by stringent pricing regulations and decentralized healthcare systems, making localized sales expertise essential.

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Perficient: Drug Development

FEBRUARY 13, 2024

What to Expect Understanding HIPAA-Ready regulations and how Adobe addresses it: A review of HIPAA regulation and the relevance in healthcare commerce. 3 Ways Adobe Commerce Elevates Pharmacy Services EST Secure Digital Conversion: Unveiling Adobe’s HIPAA-Ready Commerce Solution webinar hosted by CMSWire.

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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

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. Now, the proposed list is out, and its limited length may be a surprise to stakeholders.

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Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. In early 2023, AgencyIQ conducted a landscape analysis of DCT policy in the U.S.

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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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FDA Law Blog: Biosimilars

MARCH 27, 2023

Baumhardt, Senior Medical Device Regulation Expert — The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. This transition does not apply to Class I devices that had a Universal Product Code (UPC).

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Advarra

APRIL 30, 2024

Verify names, address(es), and other relevant information are correct for the following: All investigator sites where the participants are seen for trial procedures and the investigational product (IP) shipment address(es) are recorded in section 3. In some countries, local regulations may indicate the sub-investigators need to sign as well.

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The Pharma Data

JANUARY 18, 2021

In yesterday’s online edition of Forbes magazine, Ahmad Doroudian, CEO of BetterLife, further emphasized the significant barriers that current regulations impose on development of the current generation of psychedelics and LSD based compounds and advantages of non-controlled second generation psychedelics such as TD-0148A.

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Common Sense for Drug Policy Blog

JANUARY 5, 2024

Melatonin, the hormone involved in the regulation of our biological clock, is released when we are exposed to daylight. Three years after the war, in 1948, the Japanese Ministry of Health prohibited the production of both tablet and powder form of methamphetamine. As Crary ( 2013 , p.

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The Pharma Data

NOVEMBER 16, 2020

We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. The stability at refrigerated conditions allows for storage at most pharmacies, hospitals, or physicians’ offices.

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products.

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The Pharma Data

NOVEMBER 9, 2020

Dr. 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. ” Prof. SOURCE: XPhyto Therapeutics Corp. . View source version on accesswire.com: [link]. .

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FDA Law Blog: Biosimilars

JUNE 16, 2023

Prohibition on Excessive Price Increases The law prohibits manufacturers from imposing or causing to be imposed an “excessive price increase,” whether directly or through a wholesale distributor, pharmacy, or similar intermediary, on the sale of any generic or off-patent drug sold or dispensed to any consumer in the state.

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Perficient: Drug Development

MARCH 19, 2024

HCO’s are accelerating business transformation by shifting from a project to a product-driven approach , which supports greater agility and responsiveness to regulatory change, industry trends, and consumers’ shifting expectations.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The road to research on psychedelic products is paved with obstacles.

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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. A potential fifth standard?

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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

MARCH 6, 2024

We optimised the profile of the chemical series by simultaneously addressing multiple critical endpoints and balancing requirements in terms of potency, safety, CNS penetration and ADME profile (bioavailability, half-life, metabolism etc), aiming to solve a complex target product profile and to overcome these design challenges.

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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.-level, The report notes that these products cover “a broad set of supply chain specifics.”

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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. covered insulin product or vaccine). 1395w-114c(b)(4)(B)(i).

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Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products. Expiration dates must correlate with the storage conditions stated in the product labeling.

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Codon

FEBRUARY 13, 2024

By 2004, over a dozen companies were working on developing phage products and therapies, in locations ranging from Baltimore to Bangalore, where ten years previously, there had been none. Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries.

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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

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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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The Pharma Data

MAY 27, 2022

“We have made tremendous progress, including notable steps in just the past week, which will allow us to immediately begin bringing specialty and infant formula products into the U.S. It is our goal to ensure that hospitals, specialty pharmacies, and retail store shelves will begin seeing adequate supplies again in the coming weeks.”.

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Agency IQ

DECEMBER 11, 2023

BY RACHEL COE, MSC | DEC 6, 2023 5:27 PM EST The push and pull: Trends in oncology After the creation of the Accelerated Approval Pathway, several policies in the early 2000s were put in place with the goal of getting cancer products to patients faster. OCE has also been busy this year.

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Agency IQ

OCTOBER 20, 2023

Biosimilars are biological products that are highly similar (but not identical) to a previously approved biological product and have “no clinically meaningful” differences relative to the original reference product. Hence, they are “similar” – not the same – as the reference product.

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Alta Sciences

MAY 16, 2025

At the time, GLP regulations were becoming more enforceable, studies conducted with a casual adherence, i.e., in the spirit, to GLPs were viewed as retrospectively inadequate and would no longer fly with the standards required by the FDA, Environmental Protection Agency (EPA) and other regulatory bodies.

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