The Pharma Data

JANUARY 27, 2021

Our objective is to work with Bruker and our clinical partners to deliver an effective and high throughput assay protocol, that can be applied in the clinical setting, with the required sensitivity and specificity and CE/FDA approvals to provide a useful additional diagnostic tool in the fight against the coronavirus.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Codon

JULY 14, 2024

While blood doesn’t fit neatly into the various definitions of an organ , it still comprises a discrete system with specific functions. Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks. It can be frozen or freeze dried.

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The Premier Consulting Blog

OCTOBER 11, 2022

The treatment had been granted breakthrough therapy designation, but FDA approval would ultimately rest on the sponsor’s ability to demonstrate clinically meaningful improvement. Key Takeaway RWD and RWE play an important role in rare diseases, where capturing relevant data to support drug development is challenging.

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Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Following this process, FDASIA directed the FDA to submit a report to Congress summarizing its findings.

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Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. The sponsor-initiated IND is conducted by a pharma company seeking commercial approval. Q: What is the definition of a drug? A: For FDA 1572 is a Statement of Investigator under US Regulations/Laws.

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Advarra

JANUARY 23, 2024

FDA approval of a new drug for the condition under study) Impact of participation on alternative therapies (e.g., IRB Review of Minor Study Changes Federal regulations and guidance do not provide a singular definition for “minor” changes to research. a data breach) Decrease in expected benefits to participation (e.g.,

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Drug Target Review

OCTOBER 17, 2024

This year we completed investigational new drug (IND) enabling studies of ONC-841, which is an antagonist of Siglec-10, and received US Food and Drug Administration (FDA) approval for first-in-human study (FIH) in patients with solid tumours. The first patient has been dosed in the last quarter.

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Vial

JUNE 12, 2024

PROs, included in clinical trials as primary or secondary endpoints , are increasingly recognized by regulators, clinicians, and patients as valuable tools. Role of PROs in drug approvals A recent review sought to comprehensively characterize the inclusion of PROs and regulatory considerations in FDA-approved novel oncology drugs.

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Agency IQ

JUNE 7, 2024

BY CHELSEY MCINTYRE, PHARMD | JUN 3, 2024 8:43 PM CDT Regulatory background: DSHEA and dietary supplements The Dietary Supplement Health and Education Act ( DSHEA ) of 1994 defines the FDA’s authority in the regulation of dietary supplement products and dietary ingredients. See AgencyIQ’s analysis of the draft guidance here. ]

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Agency IQ

NOVEMBER 3, 2023

So what about all of the “biotic” terms that pop up in the news, on products labels and even in FDA warning letters? Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community.

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Agency IQ

MAY 17, 2024

Following FDA approval, these products are granted seven years of marketing exclusivity, preventing FDA from approving the “same drug for the same disease or condition” if the applicant does not have the right to reference the product (i.e., DORIS MATSUI (D-Calif.) and GUS BILIRAKIS (R-Fla.), TAMMY BALDWIN (D-Wisc.).

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Agency IQ

JUNE 2, 2023

The FDA recently concluded its work on a proposed rule focused on PMI. The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The content of the PMI : The regulation describes, in broad terms, what must be included in the PMI.

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Agency IQ

NOVEMBER 10, 2023

The delayed enforcement is part of FDA’s finalized guidance, “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.” NOV 8, 2023 10:02 PM CST Regulatory background The Federal Food, Drug, and Cosmetics Act (FD&C Act) is administered by the Food and Drug Administration (FDA) and regulates cosmetics.

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Agency IQ

APRIL 26, 2024

For context, while prescription drug products are required to comply with FDA’s regulatory requirements around labeling and approval (see 21 CFR 201 ), promotional materials and advertisements are regulated differently (under 21 CFR 202.1(1)(2) Read AgencyIQ’s analysis of this guidance here.] Yes, the guidance confirms.

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Agency IQ

MAY 31, 2024

The intended benefit for sponsors of this approach is that products making use of designated platforms would be eligible to receive expedited development benefits from the FDA, including access to early-stage development meetings with regulators. How can sponsors “prove” that these three criteria are met?

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Agency IQ

SEPTEMBER 22, 2023

In 1972, when regulatory authority for biologic products was transferred from the National Institutes of Health (NIH) to the FDA, the agency extended the two-study framework to biologic regulation as well. The Heckler case helped to refine the definition of “substantial evidence” in two important ways.

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The Pharma Data

JANUARY 9, 2021

See “Reconciliation of Non-GAAP Measures” for a definition of the terms and reconciliation tables.). 1) See “Reconciliation of Non-GAAP Measures” for a definition of terms and applicable reconciliation tables. The Company’s definition of these non-GAAP measures may differ from similarly titled measures used by others.

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The Pharma Data

FEBRUARY 8, 2021

2 The study included patients with mCSPC with both low- and high-volume disease, those who were newly diagnosed, and those who had received prior definitive local therapy or prior treatment with up to six cycles of docetaxel for mCSPC. The recruitment period for the study spanned from December 2015 to July 2017. ERLEADA ® received U.S.

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Agency IQ

MAY 31, 2024

sensitivity and specificity) – including colonoscopy procedures and an FDA-approved stool-based test ( Cologuard ) – but comparatively low uptake, given the prevalence of CRC in the population. Analysis & What’s Next Up front, the advisory committee panel meeting touched on several hot topics in diagnostics regulation.

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Agency IQ

DECEMBER 1, 2023

Over the course of the PHE—which spanned more than three years—the FDA used its expanded authority extensively to issue new direct-to-final guidance documents, creating over 80 in total. The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion.

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The Pharma Data

JANUARY 29, 2021

In the study, the definition of severe COVID-19 disease included laboratory-confirmed SARS-CoV-2 and one or more of the following: signs consistent with severe systemic illness, admission to an intensive care unit, respiratory failure, shock, organ failure or death, among other factors. COV2-S (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

JUNE 18, 2021

Patients who did not meet the definition of confirmed uMRD were randomized 1:1 to receive open-label treatment with ibrutinib or continued ibrutinib + venetoclax. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. BTK signaling is needed by specific cancer cells to multiply and spread.

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FDA Law Blog: Biosimilars

MAY 21, 2024

OASH concluded “there is widespread current experience with medical use of marijuana in the United States” by licensed healthcare providers “operating in accordance with implemented state-authorized programs, where such medical use is recognized by entities that regulate the practice of medicine under these state jurisdictions.”

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The Pharma Data

JANUARY 5, 2021

Radius” or the “Company”) (Nasdaq: RDUS) today announced a definitive agreement to acquire the global development and commercialization rights to Benuvia Therapeutics Inc. ’s PWS is an orphan disease with major endocrine and behavioral manifestations and no FDA-approved therapies for the treatment of hyperphagia.

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The Pharma Data

MAY 13, 2021

Low Level Light therapy (LLLT), is FDA approved for treating conditions such as chronic joint pain and slow to heal wounds. (3). Carl was taking ibuprofen and opiates to manage the pain, but knew he had to be careful to regulate it because of the kidney and liver problems it could cause. In the USA at an FDA approved plant.

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

MARCH 7, 2024

Basics of the bill: FDA’s budget is staying generally level The bill would keep the FDA’s appropriations (i.e., the Congressionally funded portion of the FDA’s total budget) level. billion in “definite user fees.” Per the budget table , this is actually a (relatively) small decrease for the FDA.

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Agency IQ

MAY 3, 2024

With the new LDT final rule, FDA works to clarify what emergency response will look like going forward The Covid-19 pandemic highlighted some gaps in existing policy for how tests and diagnostics are regulated and deployed in emergency situations. In the U.S. IVDs are defined at 21 CFR 809.3(a), The rule amends 21 CFR 809.3(a)

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Drug & Device Law

FEBRUARY 14, 2024

The court also ordered a more definite statement with respect to the manufacturing defect claim. That more definite (except it really wasn’t – more on that later) statement arrived in the form of a Second Amended Complaint. Have you heard the definition of insanity as doing the same thing and expecting a different result?

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Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). & Com.

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Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. That’s significant because the labels for over 500 drugs already have such information, under a voluntary FDA program. 4th 210 (5th Cir. Gilead Sciences, Inc. 2023 WL 6390598 (N.D.

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Drug & Device Law

SEPTEMBER 11, 2023

In our line of work, much of what we do depends on the continuing validity of how the FDA regulates prescription medical products. It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions. FDA , 727 F. That’s why Buckman Co. 1, 6 (D.D.C.

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Drug & Device Law

AUGUST 28, 2023

It has generally been assumed that such plaintiffs, while free to seek an advisory opinion from the FDA, may not collaterally attack FDA decisions in other litigation. FDA , 727 F. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. E.g. , Estee Lauder, Inc. 1, 6 (D.D.C.

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Drug & Device Law

JULY 25, 2023

The central issue in the Vepuri case was the portion of the conspiracy charge alleging that the three defendants conspired to violate provisions of the Food, Drug and Cosmetic Act that prohibit introducing a “new drug” into interstate commerce unless an FDA approval is “effective with respect to such drug.” section 355(a).

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Drug & Device Law

DECEMBER 30, 2022

But the usual is more common than the unusual by definition. When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. Stryker Corp. ,

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