Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JANUARY 19, 2024

approval and discussion with the FDA, the company announced in December 2023 that it intends to re-submit the biologics license application in the U.S. The clinical package, safety and label were not affected. Based on the E.U. Ebglyss (lebrikizumab; Almirall) received a Complete Response Letter (CRL) from the U.S. FDA in October 2023.

Biosimilars 40

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Agency IQ

JANUARY 26, 2024

This report also refers to an article in the Wall Street Journal indicating that, between 1993 and 1998, the government spent $3.9 What happens when a drug is not stored in its original container or within a licensed facility? million on stability testing for the SLEP program, resulting in $263.4 million in savings on drug expenses.

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Codon

APRIL 2, 2023

This is Codon Digest, a weekly roundup of research papers, news articles, and industry highlights about engineered biology. Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. Academic licenses had lower royalty rates, deal sizes, and pre-commercial payments compared to corporate licenses.

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DNA RNA Engineering Licensing 52

Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI).

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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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Agency IQ

OCTOBER 6, 2023

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). AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. What’s next? Stay tuned.

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FDA Biosimilars Science Drugs 52

Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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Regulations FDA Science Production 40

FDA Law Blog: Biosimilars

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous.

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Drugs FDA Licensing Licensing 59

Agency IQ

JULY 22, 2024

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). AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database.

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Clinical Trials Trials Science FDA 52

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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FDA Science Regulations Production 40

Codon

MAY 2, 2023

A massive mosquito factory is under construction in Brazil, according to a recent article in Nature. Once the mosquito factory has made all these insects, they are packaged into boxes or cups and then released in “strategic” areas within a city, like near swampy water or in dengue-ridden neighborhoods.

Engineering 52

Engineering Packaging Licensing Licensing 52

Codon

MAY 2, 2023

A massive mosquito factory is under construction in Brazil, according to a recent article in Nature. Once the mosquito factory has made all these insects, they are packaged into boxes or cups and then released in “strategic” areas within a city, like near swampy water or in dengue-ridden neighborhoods.

Engineering 52

Engineering Packaging Licensing Licensing 52

Codon

JULY 27, 2023

I could write an entire article in response, but if you want to go deeper into this subject, I suggest you read it in full. From an article in Science : “After 6 months, the most promising varieties had their lignin content reduced by 49.1% A ribosome in a human cell adds five amino acids to a protein chain each second.

Therapies 52

Therapies RNA DNA Engineering 52

Codon

JULY 27, 2023

I could write an entire article in response, but if you want to go deeper into this subject, I suggest you read it in full. From an article in Science : “After 6 months, the most promising varieties had their lignin content reduced by 49.1% A ribosome in a human cell adds five amino acids to a protein chain each second.

Therapies 52

Therapies RNA DNA Engineering 52

Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

FDA 40

FDA Science Biosimilars Regulations 40

Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

NOVEMBER 3, 2023

The prebiotic may either feed the probiotic that it is packaged with, or it may feed another beneficial microbe that is intended to complement the activity of the probiotic. Taken together, these two provisions indicate that a live organism that is a constituent of an article that is commonly used as human food or drink (e.g.,

Therapies 40

Therapies Science FDA Production 40

The Pharma Data

MAY 13, 2021

I did find one article that caught my eye. So go ahead and choose your discounted package of HB5 right now…. And the answer is to simply click on one of the packages you see below right now…. Once you’ve selected your package…. Right now I want you to go ahead and select one of the three packages you see below….

Production 52

Production Packaging Doctors Research 52

Agency IQ

DECEMBER 1, 2023

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

FDA 40

FDA Science Regulations Production 40

Agency IQ

JANUARY 12, 2024

The supply chain could only contain three entities: The manufacturer, the Foreign Seller (who must also be a licensed wholesaler by Health Canada), and the importer. label for that product, including patient labeling such as Medication Guides and patient package inserts.

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FDA Approval FDA Science Drugs 40

Agency IQ

JUNE 16, 2023

On the other hand, reporting and recordkeeping requirements for asbestos under TSCA section 8(a) should be published which would require manufacturers and processors of asbestos and asbestos-containing articles to report exposure-related information, quantities manufactured or processed, and employee data, among other information to the EPA.

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Regulations Compliance Production Science 40

Drug Target Review

FEBRUARY 19, 2025

If the data package (including safety) is well thought out and developed from the beginning, regulations can be a support to frame the development journey. Cedrone echoed this perspective, emphasising that regulatory guidelines should be viewed as an enabler, not a barrier.

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Therapies Molecular Biology Regulations Packaging 59

Perficient: Drug Development

MARCH 8, 2025

Purpose of This Framework This article examines the essential components of responsible design, showcases institutions that have successfully implemented ethical design practices, and provides practical strategies for navigating the challenges of organizational transformation.

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Compliance Production Marketing Regulations 72

Codon

JANUARY 21, 2024

Sign up to receive articles from Asimov Press. We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. I can't patent it and license the fact that it is safe and feasible to do a challenge study with disease sample X to my competitors.

Vaccine 126

Vaccine Trials Disease Treatment 126

Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Regulations FDA Science Production 40

Codon

FEBRUARY 23, 2025

This article concludes Issue 05. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. All the participants in the study received PrEP because it would have been unethical to deprive them of an existing, licensed preventative. We’ll see you in a few weeks for Issue 06! million by 2004.

Clinical Trials 70

Clinical Trials Virus Vaccine DNA 70

Drug & Device Law

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence.

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Drug & Device Law

JULY 31, 2023

The now-venerable Restatement (Second) of Torts §402A (1965), describes “products” as “chattels” or “articles.” The 2005 revisions to Article 2 excludes “information” from the definition of goods and also defines computer software as “information.” Digital files were not “articles,” which must be “material things.” at 1291-92.

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Production Trials International Government 52

Drug & Device Law

JUNE 13, 2022

That requirement comes with an exception: Provided, however , That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. 3d at 1286.

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