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.

Clinical Trials 52

Clinical Trials Trials Science FDA 52

Agency IQ

JANUARY 12, 2024

FDA received its most recent statutory authority to collect fees through PDUFA VII on September 30, 2022, when it passed user fee reauthorization as part of the Continuing Resolution to fund the federal government. According to Downey, the timeline of pre-license inspections for biologics can create challenges.

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FDA Drugs Production Licensing 40

Codon

JANUARY 21, 2024

A 2022 survey identified 284 human challenge trials that have been conducted since 1980. We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. Sign up to receive articles from Asimov Press. Why are challenge trials becoming more popular?

Vaccine 124

Vaccine Trials Disease Treatment 124

The Pharma Data

OCTOBER 27, 2020

The study design includes two stages of data analysis – upon 12-month data collection, anticipated in the second half of 2021, and upon 24-month data collection, anticipated in the second half of 2022. patients during the review of the NexoBrid Biologics License Application (BLA).

Clinical Trials 40

Clinical Trials Licensing Licensing FDA 40

Agency IQ

JANUARY 26, 2024

In its 2022 annual report to Congress on drug shortages, the FDA notes that one method of mitigating a shortage – once the agency is aware of the shortage at all – is “reviewing requests for extensions of expiration dating.” What happens when a drug is not stored in its original container or within a licensed facility?

Science 40

Science FDA Production Packaging 40

Agency IQ

JUNE 16, 2023

The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. The latest update, announced this week, is known as the Spring 2023 Unified Agenda. Of those 51, just four are new to the Agenda, having never before been made public.

Regulations 40

Regulations FDA Science Production 40

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). The FDA recently concluded its work on a proposed rule focused on PMI.

FDA 40

FDA FDA Approval Production Regulations 40

Codon

JULY 27, 2023

A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). Two of these proteins are about 30% the size of Cas9 , and thus much easier to package into viruses for gene therapy. No longer.

Therapies 52

Therapies RNA DNA Engineering 52

Codon

JULY 27, 2023

A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). Two of these proteins are about 30% the size of Cas9 , and thus much easier to package into viruses for gene therapy. No longer.

Therapies 52

Therapies RNA DNA Engineering 52

Agency IQ

JULY 8, 2024

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED JUN 28, 2024 6:45 PM CDT What we expect to be talking about in July and August Chevron Shakeout : Just how soon will it take for companies to begin attacking FDA over the recent Loper Bright Supreme Court case overturning the Chevron Doctrine?

FDA 40

FDA Science Regulations Production 40

The Pharma Data

AUGUST 3, 2021

Top-line results from the event-driven confirmatory Phase 3 study comparing LUMAKRAS to docetaxel in patients with KRAS G12C-mutated advanced NSCLC are expected in H1 2022. Data from the Phase 2 monotherapy study in patients with KRAS G12C-mutated solid tumors other than NSCLC and CRC are expected in H1 2022. Tezepelumab.

Biosimilars 52

Biosimilars Production Treatment FDA 52

Agency IQ

AUGUST 2, 2024

By Alexander Gaffney, MS, RAC | Aug 31, 2022 6:50 PM CDT | Updated Jul 29, 2024 9:45 PM CDT What we expect to be talking about in August and September The end of the fiscal year (and a budget showdown or shutdown) : The last day of the government’s fiscal year is September 30, which will mark an especially busy period for the FDA.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

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FDA Science Regulations Production 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. In 2022, the FDA approved the first LBP – Rebyota (RBX2660; Ferring Pharmaceuticals) – but has yet to approve a recombinant LBP.

Therapies 40

Therapies Science FDA Production 40

Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JULY 28, 2023

And following the reauthorizations of several of the FDA’s user fee programs in late 2022 – PDUFA, GDUFA, MDUFA and BsUFA – the FDA has an enormous amount of things it has committed to doing as of October 1, 2023. Therefore many of the FDA’s deadlines are tied to the start or end of the fiscal year.

FDA 40

FDA Science Biosimilars Regulations 40

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.” In other words, a prescription written by a DEA-registered, state-licensed practitioner.

Regulations 59

Regulations Production Packaging Licensing 59

Agency IQ

JUNE 16, 2023

The Fall 2022 edition was released in January 2023. The updated supplemental proposal from 2022 would add the DINP category to the list based on hazard concerns and an updated hazard assessment for the substances. EPA issued a proposal on April 1, 2022 (87 FR 19042). Decennial Census.

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Regulations Compliance Production Science 40

Agency IQ

JANUARY 12, 2024

In March 2022, the FDA held a meeting with representatives from several states, the National Academy for State Health Policy, and HHS to help assist states with their respective SIP process. The May 2022 guidance didn’t make clear if this PIR must be submitted each and every time a shipment is expected.

FDA Approval 40

FDA Approval FDA Science Drugs 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 joined Catalent in 2022, bringing with him 18 years of experience in biotech, including key roles at Lysogene SA and Cellectis SA.

Therapies 59

Therapies Molecular Biology Regulations Packaging 59

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

Because of PEPFAR’s effectiveness, the United Nations (UN) set an ambitious goal in 2022 to end HIV transmission and eliminate AIDS-related deaths by 2030. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. Half of the participants received lenacapavir, and the other half an injectable placebo.

Clinical Trials 68

Clinical Trials Virus Vaccine DNA 68

Drug & Device Law

FEBRUARY 29, 2024

The other defendant manufactures a rheumatoid arthritis medicine, tocilizumab, but contracted with the federal government to conduct clinical trials regarding its use in treating COVID-19 leading to an Emergency Use Authorization in June 2021 and full approval for COVID-19 use in December 2022. 247d-6d(a)(2)(B). In Saldana v.

Government 59

Government Production FDA Clinical Trials 59

Drug & Device Law

JANUARY 4, 2024

2022) (same result as to other COVID-19 vaccine). April 13, 2022) (available here ). 2022) (quoting this publication). “The 2022) (“Willful-misconduct claims may proceed only in the federal district court for the District of Columbia.”); Maglioli v. 247d-6d(b)(8). 25, 2023); Goins v. 3d 745, 753 (E.D. Franklin ). “[T]here

Vaccine 59

Vaccine FDA FDA Approval Production 59

Drug & Device Law

DECEMBER 29, 2023

As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. 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. Sanofi Pasteur Inc.

Testimonials 105

Testimonials Drugs FDA Vaccine 105

Drug & Device Law

JULY 31, 2023

171, 212 (Fall 2022). Uber Technologies , 2022 Cal. March 22, 2022) (same); Shaff v. 2022), review denied (Cal. Uber , 2022 WL 2031868, at *2 (Cal. July 13, 2022) (similar language). 2022 WL 551701 (N.D. 3d , 2022 WL 16752071 (C.D. 2022 WL 16747282, at *9 (S.D. Meta Platforms, Inc.

Production 52

Production Trials International Government 52

Drug & Device Law

MAY 15, 2023

include[s] licensed health care professionals or other individuals who are authorized to prescribe, administer, or dispense a covered countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. 2022), the intermediate appellate decision that we discussed here. 2022); Pisano v.

Vaccine 59

Vaccine Pharmacy Hospitals Licensing 59

Drug & Device Law

NOVEMBER 1, 2022

16, 2022) (“ Mixson I ”), and Mixson v. 2022 WL 7581737 (N.D. 23, 2022) (“ Mixson II ”), by no means won everything, but what they won was more important than what they didn’t, so we’re OK with the results. 2022 WL 4364153, at *2. 2022 WL 4364153, at *2. Mixson I , 2022 WL 4364153, at *5. Bard, Inc. ,

Testimonials 59

Testimonials FDA FDA Approval Packaging 59

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. 2022 WL 970681 (N.D.

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Testimonials Licensing Licensing FDA 59

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. Somatics, LLC , 2022 WL 989469 (9th Cir. April 1, 2022) (the companion case to this ). W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . .

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Testimonials Doctors Production Laboratories 59

Drug & Device Law

MARCH 16, 2022

2022 WL 604889 (D. Arizona March 1, 2022) – focuses on the regulatory status of the device. The pelvic mesh case of the week – McBroom v. Ethicon, Inc. We always knew it was an important issue, and McBroom provides yet another reason why that is so.

FDA 69

FDA Production Trials Government 69