Drug Channels

DECEMBER 9, 2022

Leslie and Jinghong discuss the terms of health insurance startups CEOs’ compensation packages. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. They explain why the reported CEO total compensation numbers are deceiving. Access the full findings from AIS’ Healthcare Executive Compensation Survey here.

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biobide

NOVEMBER 20, 2023

Background on the Cosmetics industry In 2022, the value of the global cosmetics market was estimated to be worth USD 262.21 Additional contributing factors include an increased awareness of fashion trends, innovations in the areas of hair coloring and skincare product formulations, and developments in the area of packaging.

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Practical Cheminformatics

JANUARY 3, 2023

Here’s a roundup of some of the papers I found interesting in 2022. Based on papers I read and reviewed in 2022, there seems to be a perception that Deep Neural Networks have become ubiquitous in QSAR modeling. I’m sure someone (not me) will write an entire review on the advances in PSP during 2022. QM Methods 6.

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Drug Discovery World

JANUARY 23, 2024

The platform was recently updated to support FDA 21 CFR Part 11 compliance and include a full Installation Qualification / Operation Qualification (IQ/OQ) package for pharmaceutical quality assurance, extending the system’s applications into drug manufacturing operations. The consortium has been awarded €3.4

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The Premier Consulting Blog

MAY 4, 2023

billion in 2022 and is expected to grow approximately eight percent from 2023 to 2030 [1]. Food and Drug Administration (FDA) published in March of 2022 pertaining to ophthalmic drugs and devices, titled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. Market Analysis [2] Aloba O, et al. Regulatory Focus.

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Drug Discovery World

NOVEMBER 7, 2022

In July 2022, we convened a group of drug discovery experts, comprising Psychiatry Consortium Industry Partners, members of the British Neuroscience Association and representatives from academic institutions to discuss the approaches and considerations for target validation projects. . DS: Do you have funding available at the moment? .

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Drug Discovery World

JULY 22, 2022

In June 2022 we were approved for CSIRO’s kickstart grant, which provides up to $100k AUD toward setting up and running that custom assay program.” Psylo started using CDD Vault during early 2022, and has spent time importing all of its existing experimental and compound data into the platform.

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The Premier Consulting Blog

APRIL 27, 2023

Starting in 2016, many versions were developed through internal collaboration and change requests until, in 2022, eCTD v4.0 Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5 Implementation Package v1.5 Module 1 Implementation Package FDA eCTD v4.0

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The Premier Consulting Blog

OCTOBER 1, 2023

The FDA introduced the Type D Meeting on October 1, 2022, as part of the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter. Prescription Drug User Fee Act (PDUFA) VII The Prescription Drug User Fee Act (PDUFA VII) is a law that was signed and took effect on September 30, 2022.

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Agency IQ

NOVEMBER 20, 2023

EMA publishes first electronic Product Information as pilot progresses In 2022, the European Commission, Heads of Medicines Agencies and EMA established a common standard for electronic Product Information, or ePI, an electronic representation of information patients usually receive in paper format along with their medicines.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different.

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Agency IQ

SEPTEMBER 15, 2023

The division followed suit with perfluorohexane sulfonic acid (PFHxS) on October 31, 2022, issuing drinking water notification levels of 3 ppt and response levels of 20 ppt for the chemical. In early January 2020, DTSC also held a workshop on PFAS in food packaging , including panel discussions and presentations on potential alternatives.

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Perficient: Drug Development

MAY 9, 2024

Shortly after, in September 2022, a group of liaisons was formed in Atlanta so we could start to give back to our local community in person. While we were putting together the care packages and organizing clothing, we even noticed a few unhoused people come in and grab shoes and clothes they needed.

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Agency IQ

MARCH 15, 2024

Background: SB 54 and its requirements On June 30, 2022, Governor Gavin Newsom signed into effect SB 54, the Plastic Pollution Prevention and Packaging Producer Responsibility Act. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.

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FDA Law Blog: Biosimilars

MARCH 8, 2023

Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023. This was deployed to pre-production on August 19, 2022 and implemented in eMDR and eSubmitter the same day.

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Drug Discovery World

FEBRUARY 8, 2023

In AAV therapeutics, empty capsids are those that are not packaged with the therapeutic DNA. Partially-filled capsids may also be present, and contain packaged process-related impurities or truncated genetic material. DDW Volume 24 – Issue 1, Winter 2022/2023 References: Wright JF. Published online January 20, 2022:1-7.

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Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. Two notes on statutory authority: Front of package labeling and banning devices. AgencyIQ has the highlights.

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The Pharma Data

DECEMBER 10, 2020

” Sildenafil and T razodone T ablets Recalled After Being Packaged Together. Sildenafil and trazodone tablets have been recalled by pharmaceutical distributor AvKare because the drugs were “inadvertently packaged together” when they were bottled by a third-party vendor, according to the company. © 2020 HealthDay.

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Drug Discovery World

AUGUST 4, 2022

This should become easier, as the FDA is expected to publish a guidance document on EPRs by end of 2022. Biographies: Gurmeet Singh is Senior Director at West Pharmaceutical Services, a provider of pharmaceutical delivery and packaging systems. She has more than 15 years of experience in medical device project management and marketing.

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Drug Discovery World

SEPTEMBER 29, 2022

Earlier this month, The Biden Administration announced plans for a $2 billion funding package for the biotechnology and manufacturing sector, to ensure a ‘sustainable, safe, and secure American bioeconomy’. Biden’s $2 billion biotech boost.

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The Pharma Data

FEBRUARY 19, 2022

The agency is also advising that all drugs, medical devices, cosmetics and dietary supplements, regardless of packaging, be discarded. Food in non-permeable packaging (such as undamaged glass or all-metal cans) may be suitable for use if thoroughly cleaned and sanitized. 29 and Sep. 17, 2021, demonstrating a history of infestation.

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Drug Discovery World

SEPTEMBER 29, 2022

The investigational mRNA-1647 vaccine is packaged in lipid nanoparticles, or LNPs, that are a complex assembly of four types of lipids; each LNP contains multiple mRNA molecules19. Volume 23 – Issue 4, Fall 2022. Retrieved August 10, 2022, from [link] . Retrieved August 10, 2022, from [link] . About the author.

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Agency IQ

OCTOBER 6, 2023

AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. Amanda Conti, AgencyIQ Notably, the increase from FY 2022 was largely driven by biologic products. The FY 2022 decline in NME volume does not appear to reflect a new normal for agency operations. What’s next?

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Practical Cheminformatics

DECEMBER 4, 2022

In addition, the core code for extracting ring systems from molecules has been incorporated into the latest version of my pip installable useful_rdkit_utils package. In a 2022 paper, Peter and coworkers used data from the ChEMBL database to identify sets of ring systems with similar biological activity. Altmann, E., Racine, S., &

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Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing?

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Agency IQ

FEBRUARY 23, 2024

In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging.

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The Premier Consulting Blog

MAY 11, 2023

In March of 2022, the agency issued a guidance document titled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. Case 2: Approved Product Omlonti® (omidenepag isopropyl ophthalmic solution, 0.002%), was approved in September 2022. United States Food and Drug Administration court decision.

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Drug Discovery World

AUGUST 24, 2023

In October 2022, clinical stage company Beckley Psytech entered into an agreement to acquire clinical-stage life science company, Eleusis Therapeutics. In the study – the largest of its kind – psilocybin proved effective as a therapy for treatment-resistant depression (TRD). So, where is the money?

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Eye on FDA

APRIL 13, 2022

We are four months into the year, and this week OPDP has issued its fourth regulatory action letter of 2022. In fact, over the past two years, the office issued only a total of 6 letters which means 2022 is going at a heightened clip.

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FDA Law Blog: Biosimilars

DECEMBER 14, 2023

In October 2022 President Biden asked the Secretary of HHS and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” As explained more fully explained below, that impression would be partially correct, but partially incorrect.

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Agency IQ

JANUARY 19, 2024

For example, in 2023, the EMA published its 2022 highlights report on February 16, followed by the detailed report on May 15. This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021. The EMA has now seen a three-year decline in new active substances, with 54 in 2021, 44 in 2022 and 39 in 2023.

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FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Whether a firm used the 10-day call and/or an SIR, it should include any prior feedback from those interactions with FDA in the AI response and describe how and where in the AI response package the prior feedback was addressed.

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Agency IQ

DECEMBER 15, 2023

The EPA orders prohibit the nine significant new use notices the company submitted in December 2022 and are effective February 28, 2024. In addition, fluorine gases are used on high density polyethylene (HDPE) plastic packaging to improve container stability. BY PATRICIA ISCARO, ESQ., EPA first discovered this in pesticides.

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Perficient: Drug Development

OCTOBER 25, 2023

LEARN MORE: Read Perficient’s 2022 Community Impact Report So, which office won our 2024 HAM Competition? Participating offices that made the biggest impact in their communities qualify for special recognition and bragging rights as the 2024 HAM Champions. Stay tuned to find out!

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Agency IQ

NOVEMBER 10, 2023

Cosmetics must also be in compliance with the Fair Packaging and Labeling Act ( FP&L Act ); however, only color additives require FDA approval before they may be used in cosmetics. On December 29, 2022, as part of the Consolidated Appropriations Act, 2023 , the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law.

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Drug Discovery World

MARCH 13, 2023

They can manufacture the drug substance and then pass it to a specialised fill-finish facility that will load it into its final sterile packaging.   Conversely, cell therapy manufacturing starts with a highly heterogeneous source material: human blood. April 4, 2022. References “Approved Cellular and Gene Therapy Products.”

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Agency IQ

MARCH 7, 2024

BY WALKER LIVINGSTON, ESQ | MAR 5, 2024 6:33 PM CST Background: Food chemical safety at the FDA The FDA has primary authority over the chemicals used in food, including those used as food additives, colorants, in food packaging and more. The FDA is also currently reviewing a Food Additive Petition filed on May 2, 2022.

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