Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 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.

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FDA Law Blog: Biosimilars

JUNE 26, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. package labeling is optional). not subject to premarket review).

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FDA Law Blog: Biosimilars

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

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The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. The FDA is working with the company to initiate a voluntary recall External Link Disclaimer of the affected products. Recalls, Market Withdrawals & Safety Alerts Report a Problem to the FDA. ###.

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Agency IQ

MARCH 7, 2024

FDA updates list of chemicals in the food supply under agency review The FDA has announced an update to its List of Select Chemicals in the Food Supply Under FDA Review, which details the agency’s ongoing post-market assessments for chemicals in human food.

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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. This is what OIRA is currently reviewing.

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Agency IQ

JUNE 26, 2023

FDA quietly kicks off process that could inform future rare disease regulatory reforms Reforms buried within the FY2023 omnibus spending bill require the development of a new report looking at the regulatory processes of the U.S. legislators have asked the FDA to study the way that rare disease drugs are regulated in the U.S.

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Agency IQ

SEPTEMBER 6, 2023

But as a new guidance document clarifies, the FDA need to receive certain information from companies to make this meeting type work, and its not in a rush to receive requests, either. FDA Warning Letters are often sent to manufacturers of generic drugs.

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FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. And the Guidance may be used as leverage to secure action from FDA on a meeting request.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. §

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Agency IQ

MARCH 1, 2024

Explainer: What a government shutdown would mean for the FDA (Updated) With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1. The appropriations bills that expire March 1 include the Agriculture-FDA appropriations bill.

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FDA Law Blog: Biosimilars

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. b)(1)(iii).

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FDA Law Blog: Biosimilars

JANUARY 3, 2024

Enter the FDA’s Center for Veterinary Medicine (“CVM”). A longstanding component of the FDA and its predecessor, CVM, in its initial form as part of the Department of Health, Education, and Welfare, was established in 1965 and evolved in CVM by 1984. And CVM certainly exercises that authority.

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The Premier Consulting Blog

NOVEMBER 16, 2022

Therefore, when excipients are selected for formulating a new drug product, it is essential that they either meet current FDA standards or are qualified for use in the drug product. Involving nonclinical/toxicology experts early on is key to reducing the package of studies as much as possible.

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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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Advarra

SEPTEMBER 8, 2022

One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11. In 1997, FDA released regulations providing guidance on the use of electronic systems.

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FDA Law Blog: Biosimilars

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. Effect on FDA approvals— In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid using a covered equipment or service, will it need to file supplements with FDA for the CMC update?

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Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness.

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Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. Without sufficient resources, the FDA is unable to do so. modernization efforts.

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The Pharma Data

FEBRUARY 13, 2022

One of the FDA’s signature efforts to improve our nation’s nutrition is focused on reducing the level of sodium in the food supply. The FDA took a critical step to help reduce sodium through a recently released guidance that establishes voluntary sodium reduction targets in processed, packaged and prepared foods.

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The Premier Consulting Blog

NOVEMBER 8, 2022

e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., typical drug device, biologic device) Two or more separate components, co-packaged (e.g., Also see the FDA’s FAQs on this topic.) The drug product is packaged and shipped as a solid powder.

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The Premier Consulting Blog

DECEMBER 28, 2023

This article reviews the regulations governing charging or obtaining insurance coverage for an investigational device. How to Request Medicare Coverage The FDA communicates the assigned study category by sending the sponsors a formal letter. CMS has created a checklist to assist sponsors in submitting a complete package.

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Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. This is a question that sponsors have been struggling with for quite some time.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Existing published VCS may be identified internally by FDA or externally by stakeholders.

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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. A: No, however, then you would be dealing with seeking an IND exemption from the FDA. A: This is a complex topic and is best outlined in the FDA’s guidance document.

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Advarra

SEPTEMBER 23, 2022

The Food and Drug Administration (FDA) is the federal entity in the U.S. Before the FDA permits a pharmaceutical drug product to be lawfully marketed, sponsors are required to submit information about the product’s safety and efficacy so the FDA can determine : . The sponsor of the investigation submits an IND to the FDA; .

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The Premier Consulting Blog

OCTOBER 11, 2022

For such trials, the US Food and Drug Administration (FDA) may allow the use of credible real-world data (RWD) and real-world evidence (RWE) in lieu of data collected in a Phase 3 trial. The FDA also granted a second meeting for review. The agency requested that data be further standardized and presented by primary functional endpoint.

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Advarra

JUNE 14, 2024

Protocol and amendments Purpose: To document revisions of trial-related documents during the trial Documents: Log of protocol changes, IRB-approved protocol with principal investigator (PI) signature page, IRB-approved case report forms, IRB-approved advertisements and participant information sheets, protocol amendments Informed consent documents Purpose: (..)

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Drug Discovery World

SEPTEMBER 26, 2022

Improvements in technology and changes to worldwide regulations in life sciences has led to an increase in the availability of clinical data. Remote trials, wearable devices and advancements in genomic sequencing means that clinical data is now more abundant than ever and is only set to grow. . Global efforts . References .

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The Pharma Data

DECEMBER 14, 2020

a clinical stage biotech company developing first-in-class drugs for diseases of the immune system, announced today that the company has filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) pertaining to its drug candidate Rabeximod. STOCKHOLM , Dec. 15, 2020 /PRNewswire/ — Cyxone (publ.),

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The Pharma Data

MAY 17, 2021

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

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Advarra

JUNE 28, 2022

As a drug successfully makes it through the development process, sponsors will inevitably need to submit a new drug application (NDA) to the Food and Drug Administration (FDA). There are a myriad of regulations coming into play during the drug development process. Failure to Have a Pre-Investigational New Drug (IND) Meeting.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Revised § 820.3

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Drug Discovery World

JULY 11, 2022

It has been estimated that by 2025 the FDA will be approving 10 to 20 cell and gene therapy products per year 2. As the field matures and the risks are better understood, regulators continue to streamline duplicative and burdensome oversight efforts 5. Statement from FDA Commissioner Scott Gottlieb, M.D. 2019,January 15).

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Drug Discovery World

OCTOBER 3, 2023

Plans to overhaul the EU regulation on rare disease therapies risk undermining two decades of progress, a new report claims. The European Orphan Medicinal Product Regulation was introduced in 2000 to incentivise the development of new medicines for people living with rare disease. This could deprive around 1.5

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The Pharma Data

DECEMBER 30, 2020

Regulators said that the first dose of the vaccine had 70% effectiveness in protecting against COVID-19 in the period between the first dose taking effect and a second shot. Some people in clinical trials of the Oxford-AstraZeneca vaccine were given the two doses several months apart. Shane Erickson Inc.

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Agency IQ

NOVEMBER 20, 2023

Sentinel Update: PDUFA projects, ARIA sufficiency and building out a method for causal inference FDA’s Sentinel Initiative, the post-market, real-world data surveillance system, is nearing the end of its current five-year strategic plan. The Sentinel Initiative was kicked off in 2008 under the FDA Amendments Act (FDAAA).

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