FDA Law Blog: Biosimilars

JULY 22, 2024

s John W.M. s John W.M.

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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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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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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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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: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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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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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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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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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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Practical Cheminformatics

JANUARY 8, 2024

In 2022, several papers , including one of ours , showed the promise of active learning approaches in drug discovery. In our 2022 paper , we evaluated 5 different ML models and saw minimal differences in performance. The paper also provides links to several software packages for building MIL models.

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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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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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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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National Institute on Drug Abuse: Nora's Blog

SEPTEMBER 25, 2024

Cannabis products are often sold in colorful packages that mimic kid-friendly snack foods, for example, making them appealing to children and to young people. Published online July 15, 2022. Prevalence of Problem Gambling: A Meta-analysis of Recent Empirical Research (2016–2022). Journal of Affective Disorders. Forbes Betting.

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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

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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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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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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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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The Open Targets Blog

JUNE 21, 2022

The use of OT-UI was complicated by issues such as handling third-party library versions, developing in a local environment using NPM (node package manager), and integrating custom components. We will even be able to generate new UIs with our package scheme quickly. Integrate complex task pipelines in our codebase.

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Agency IQ

JULY 26, 2024

This includes the submission of OMORs, public comments to administrative orders, formal meeting requests and packages, dispute resolution requests, administrative hearing requests, record request responses, as well as updates to drug listing information. FDA-2022-D-2059 What should be submitted to which portal?

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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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The Pharma Data

MARCH 7, 2022

The new technique controls gene activity without altering the DNA sequence of the genome by targeting chemical modifications that help package genes in our chromosomes and regulate their activity. 2022 Mar 1;38(9):110457. These methyl groups must be refreshed so if PRC2 is blocked the genes it has silenced. it can be reawakened.

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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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The Pharma Data

MAY 2, 2022

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Sage Therapeutics, Inc. Nasdaq: SAGE) and Biogen Inc. Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S.

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The Pharma Data

NOVEMBER 4, 2020

The affected product is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg lots are under NDC 29033-056-01, lot numbers MET200101 and MET200301 which expiration date 05/2022. It can be identified as an off-white oblong tablet debossed with “NM7.”

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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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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 Pharma Data

JUNE 7, 2023

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch. Additional UpTempo platforms will follow for other modalities.

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The Premier Consulting Blog

OCTOBER 11, 2022

During that meeting, the sponsor presented data by endpoint, which complemented the data package and indicated the benefits of treatment outweighed the risks. Presentation, European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) 2022. The FDA also granted a second meeting for review.

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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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FDA Law Blog: Biosimilars

JANUARY 11, 2024

mL was approved on March 18, 2022. mL and 20 mg/0.4 mL for subcutaneous injection was approved on October 15, 2021; the supplement for 10 mg/0.2 Thus, 18 months from approval would result in expiration of FIE on April 15, 2023, and on September 18, 2023 respectively.

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Agency IQ

SEPTEMBER 6, 2023

The meeting package should contain sufficient detail to meet the intended meeting objectives,” and should also “clearly indicate” the purpose of the meeting and allow FDA to “assess the potential utility of the meeting.” What should the meeting request package include?

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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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The Pharma Data

FEBRUARY 25, 2022

The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An The FDA approval was based on the review of a comprehensive data package which demonstrated biosimilarity of ABRILADA to the reference product.

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Agency IQ

FEBRUARY 12, 2024

The agency released a proposed rule in September 2022, which laid out the plan for designating the substances (as well as their salts and structural isomers) as hazardous substances, proposing to find that the substances may present substantial danger to public health, welfare, or the environment. Another one of the bills, H.601

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