Agency IQ

SEPTEMBER 6, 2023

This impact was apparently enough for the FDA and generic pharmaceuticals industry to include a new meeting type in the most recent iteration of the Generic Drug User Fee program (GDUFA), called a “Post-Warning Letter Meeting.” What should the meeting request package include?

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The Premier Consulting Blog

MAY 4, 2023

The new guidance provides detailed information to applicants and manufacturers regarding compliance with the requirements in 21 CFR Part 4 for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers. 2] On April 16, 2021, the U.S.

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Agency IQ

MAY 3, 2024

The pharma reform package remains in E.U. voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U. On April 10, the E.U.

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Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. In the proposed revision to the European pharmaceutical legislation, both the regulation and directive introduce two very similar though distinct concepts: unmet medical need, and high unmet medical need.

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Agency IQ

NOVEMBER 27, 2023

In 2018, NDMA was first detected in the active pharmaceutical ingredient (API) for valsartan, a blood pressure drug. Investigations revealed that nitrosamine impurities were found in pharmaceutical products due to reasons outside API synthesis , through re-use of chemical precursors containing leftover contaminants.

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Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. A: Working in a pharmaceutical company is the best way to learn this. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? A: This does not usually happen.

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Agency IQ

JUNE 26, 2023

While most legislators who voted in favor for this legislation were likely unaware, the European Union is in the process of a dramatic overhaul of its Orphan Drug Regulation by way of a proposed revision of its Pharmaceutical Legislation. The NASEM notice also comes as FDA is working elsewhere to advance rare disease policy.

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Agency IQ

JANUARY 12, 2024

The data used by AgencyIQ is obtained from reports put out by CDER and CBER , as well as approval letters and review packages posted to the Drugs@FDA database. While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved.

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Agency IQ

OCTOBER 6, 2023

For an in-depth analysis of this restriction proposal, read AgencyIQ’s February 10, 2023 article here.] The specifics of the analysis campaigns facility operators must conduct are spelled out in article 3 of the ministerial order. A list of eight substances of particular note and which match these criteria is included in article 3.

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Agency IQ

APRIL 12, 2024

The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium), another industry group, cited similar concerns, describing several of the recommendations in the new draft as “somewhat confusing,” “unclear,” and/or “unrealistic.

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Agency IQ

MARCH 15, 2024

California implements a variety of extended producer responsibility (EPR), programs, including programs to address paint, carpet, mattress, pharmaceutical and battery waste. 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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Drug Target Review

DECEMBER 5, 2024

2 However, utilisation of biological systems introduces variability and by-products, as well as a challenge unique to AAV production: the assembly of full capsids with correctly packaged DNA, partially filled capsids containing partial vector and/or host cell DNA, and empty capsids.

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Agency IQ

AUGUST 2, 2024

and the E.C.

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Agency IQ

AUGUST 11, 2023

BY KARI OAKES AUG 7, 2023 10:20 PM CDT Quick background on nitrosamines in pharmaceutical products Nitrosamines are a large and diverse class of chemicals, with more than 300 different structurally distinct species known today. In 2018, NDMA was first detected in the active pharmaceutical ingredient (API) for valsartan, a blood pressure drug.

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Agency IQ

JULY 8, 2024

Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER. and the E.C.

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Molecule Blog

JANUARY 18, 2023

This is how it looks like in Typescript using the multiformats NPM package : import { CID } from "multiformats/cid"; import * as json from "multiformats/codecs/json"; import { sha256 } from "multiformats/hashes/sha2"; const checksum = async (u8: Uint8Array) => { //[link] const digest = await sha256.digest(u8);

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Agency IQ

MAY 17, 2024

Two items should be submitted concurrently to the FDA by sponsors seeking a PSUB meeting: 1) the actual meeting request and 2) the meeting package. The first hypothetical involved a topical gel product with two active pharmaceutical ingredients (APIs). What should be provided by sponsors in the PSUB meeting request?

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Agency IQ

AUGUST 25, 2023

The questions contained in the letter are organized into six high-level topics : (1) current market dynamics; (2) (regulatory) pathway; (3) federal-state interaction; (4) safety; (5) quality; and (6) form, packaging, accessibility, and labeling. The letter gave respondents until August 18, 2023 to respond to the request.

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Agency IQ

NOVEMBER 27, 2023

Many posted comments came from professional pharmacy organizations, trade groups like the Pharmaceutical Research and Manufacturers of America (PhRMA) , and pharmaceutical companies, such a Eli Lilly , Novo Nordisk and Merck.

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Agency IQ

FEBRUARY 23, 2024

The ideal approach, said Liu, would integrate early pharmacology data with model-based approaches to minimize patient exposure and speed drug development, in a fashion that can not just “benefit the patient, but also can help the pharmaceutical company as well.” And it really is the entire package that has been formed. …

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Agency IQ

JULY 12, 2024

In October 2024, the European Commission published a communication putting forth a package of reforms to address medicines shortages. The Commission’s communication was accompanied by a Q&A document defining key terms and ideas, including how the effort was related to ongoing efforts to overhaul the pharmaceuticals legislation.

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Agency IQ

NOVEMBER 3, 2023

The Pharmaceutical Group of the European Union (PGEU) conducted a survey finding shortages worsened in 2022 compared to 2021, with most European countries reporting worsening. The Pharmaceutical Strategy document notes that Covid-19 just compounded medicines shortages that had already impacted patient health and the E.U. wide level.

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Codon

APRIL 9, 2024

However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. Few journal articles were written about the project using her (or anyone’s) name before 2010. Miller and Su published an article on Tu’s story in Cell in 2011.

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Practical Cheminformatics

JANUARY 2, 2024

Review articles 2023 was a bit of a mixed bag for AI in drug discovery. To address these challenges, Buttenschoen and colleagues from Oxford University developed PoseBusters, a Python package for evaluating the quality of docked poses. Docking, protein structure prediction, and benchmarking II.

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Agency IQ

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

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Agency IQ

MAY 31, 2024

Even small changes in the Parliament’s composition could have an impact on ongoing legislative discussions, such as the revisions to the pharma reform package. The current European Parliament and Commission have confirmed their position on the pharma package, but the European Council is still working on its negotiation position.

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Agency IQ

JANUARY 19, 2024

The clinical package, safety and label were not affected. Inaqovi (cedazuridine/decitabine; Otsuka Pharmaceuticals) is approved in the E.U. According to comments from Eli Lilly – which holds the U.S. rights to the drug product – the company plans to work with the FDA and manufacturer to address the identified concerns.

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Agency IQ

OCTOBER 27, 2023

Comment periods for EMA documents (such as concept, reflection, and guidance papers) generally stay open for at least six months, though these timelines can vary drastically. policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

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Agency IQ

JANUARY 26, 2024

Pharmacopeia (USP) and the FDA – to clarify whether the “actual ‘shelf life’ of many pharmaceutical products might be considerably longer than the expiration date that appears on the manufacturer’s container.” And per the FDA, “extension of drug product expiration dating periods is strictly voluntary for pharmaceutical manufacturers.”

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Agency IQ

JULY 22, 2024

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Data on these novel approvals is published throughout the year by both CDER and CBER.

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Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Data on these novel approvals is published throughout the year by both CDER and CBER.

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The Pharma Data

MARCH 25, 2021

European Medicines Agency to Conduct First-Ever Parallel Assessment of a Medicinal Product, Takeda’s Dengue Vaccine Candidate (TAK-003), for use in the EU; Countries Outside of the EU through the EU-M4all (Previously Article 58) Procedure.

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Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

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FDA Law Blog: Biosimilars

JANUARY 3, 2024

Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.

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Agency IQ

JUNE 21, 2024

That same year, the Pharmaceutical Strategy for Europe called for a revision of the Variations Regulation and an evaluation of the existing legislation. In April 2023, the Commission issued proposals to revise the current pharmaceutical Directive and Regulation. See AgencyIQ’s analysis of the proposed Directive and Regulation.]

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Agency IQ

JUNE 16, 2023

0910-AI84 December 2023 Final Rule Stage Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

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