thought leadership

NOVEMBER 14, 2023

Food and Drug Administration (FDA) issued a proposed rule to amend its enforcement approach to Laboratory Developed tests (LDTs). If implemented, this rule would result in LDTs generally falling under similar enforcement regulations as other in vitro diagnostic (IVD) products, a significant change from existing policy.

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Agency IQ

JULY 12, 2024

BY ALEXANDER GAFFNEY, MS, RAC The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond.

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Chemical Biology and Drug Design

SEPTEMBER 30, 2023

Abstract Epigenetic regulation of genes through posttranslational regulation of proteins is a well-explored approach for disease treatment, particularly in cancer chemotherapy. Structural classification and regulatory functions of histone deacetylases and their inhibitors.

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FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

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BioPharma Drive: Drug Pricing

MAY 10, 2024

The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.

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BioPharma Drive: Drug Pricing

JUNE 9, 2023

The regulator will issue separate verdicts on the pioneering treatment’s use in sickle cell disease and beta thalassemia, with the first expected late this year.

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BioPharma Drive: Drug Pricing

OCTOBER 2, 2023

The regulator is considering approval of what would be the first CRISPR medicine, as well as important clearances for Alnylam, Bristol Myers, Amgen and Pfizer.

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Drugs.com

MARCH 25, 2024

MONDAY, March 25, 2024 -- Federal regulators are taking a second stab at banning the controversial use of electroshock devices to manage the behavior of patients with intellectual and developmental disorders.The devices deliver electric shocks to a.

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The Premier Consulting Blog

OCTOBER 30, 2024

It is recognized, however, that there is a learning curve across the industry and FDA that is inherent to the development of such novel technologies. To prevent this learning curve from becoming a roadblock on the path to regulatory approval, the FDA has developed several collaborative programs to support advanced manufacturing.

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ProRelix Research

AUGUST 3, 2023

Although the United States Food and Drug Administration (FDA) has always supported and advocated the idea of decentralized trials, the real adoption and application of decentralized aspects in trials has […] The post FDA Guidance on Advancement of Decentralized Clinical Trials appeared first on ProRelix Research.

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FDA Law Blog: Biosimilars

MARCH 10, 2024

Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. The conference, held in Washington, D.C.,

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Eye on FDA

FEBRUARY 8, 2024

Every so often is it worthwhile to look back at FDA to see what they had to say in a given year, and in addition, how they said it. In fact, the use of FDA Roundups appears to be on the rise, and this might be a factor in fewer traditional press releases coming out of FDA. Less is more? What Did They Talk About?

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FDA Law Blog: Biosimilars

JANUARY 28, 2024

Gonzalez — In a new publication in the Washington Legal Foundation’s (WLF) Legal Backgrounder , we argue that FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs) is vulnerable to legal challenge, once finalized. But, as we detail in the WLF publication: “ the MDA supplies no such clear [congressional authorization].

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Drugs.com

FEBRUARY 9, 2024

9, 2024 -- America’s most popular cold medications contain a nasal decongestant that doesn’t work, creating a knotty dilemma for regulators, a new study reports.Cold remedies containing phenylephrine remain consumers’ most. FRIDAY, Feb.

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Drugs.com

OCTOBER 27, 2023

27, 2023 -- Federal regulators have sent warning letters to two companies for illegally selling probiotic products for use in preterm infants. FRIDAY, Oct. Food and Drug Administration also sent a letter to health care providers warning of.

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Conversations in Drug Development Trends

AUGUST 23, 2023

However, patients also play a vital role in engaging directly with the FDA. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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ProRelix Research

JUNE 27, 2024

In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The […] The post Food and Dietary Supplements Clinical Trials Regulations in USA appeared first on ProRelix Research.

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FDA Law Blog: Biosimilars

JUNE 12, 2024

FDA once estimated that OTC hearing aids would save patients over $3000.) The category of OTC hearing aids was created by congressional mandate and implemented by FDA to address an “unmet public health need.” This is because “FDA officials and six external stakeholder groups. .

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Drugs.com

OCTOBER 4, 2023

3, 2023 -- Federal regulators are cautioning doctors not to give probiotics to preterm infants. TUESDAY, Oct. An infant given probiotics at an undisclosed hospital has died, U.S. Food and Drug Administration officials said in a recent warning.

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BioPharma Drive: Drug Pricing

NOVEMBER 20, 2023

The regulator plans to convene an advisory panel to discuss an expanded indication for Abecma, presenting another hurdle for Bristol Myers and partner 2seventy bio.

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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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Eye on FDA

OCTOBER 12, 2023

FDA announced this week the formation of a new advisory committee – the Digital Health Advisory Committee – for the purpose of providing the agency with advice on matters related to digital health technologies (DHT). FDA does not form new advisory committees all that often, making it a notable development in more than one respect.

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Drugs.com

JULY 3, 2024

WEDNESDAY, July 3, 2024 -- A regulation allowing the use of brominated vegetable oil in food was revoked Tuesday by the U.S. Food and Drug Administration after the agency concluded the additive was unsafe for human consumption.Brominated vegetable.

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FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

Industry has long requested input from FDA about the types of patents that can be listed in the Orange Book, and, in response, FDA asked for comments on the types of patents that should be listed. But FDA has never made an affirmative statement as to the types of patents that can be listed in the Orange Book.

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. This story goes back to the 2009 Family Smoking Prevention and Tobacco Control Act, which prohibits manufacturers from selling any “new tobacco product” without authorization from FDA.

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Drugs.com

OCTOBER 31, 2023

30, 2023 -- Federal regulators are warning consumers to stop using eyedrops and gels from several major brands after finding unsanitary conditions in a manufacturing plant. MONDAY, Oct. Twenty-six eye care products are part of the alert.

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FDA Law Blog: Biosimilars

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).

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FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. Prior to February 2, 2026, FDA also said that it does not intend to enforce complaint requirements under 21 CFR 820.198 for developers that are already in compliance with the complaint requirements under ISO 13485.

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FDA Law Blog: Biosimilars

JANUARY 8, 2024

Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. Assessing risks in regulated industry requires the appropriate depth and breadth of regulatory expertise. Deals in FDA regulated space are among the most complicated of any industry, and diligence adds cost.

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Drugs.com

APRIL 29, 2024

MONDAY, April 29, 2024 -- Laboratory tests used by millions of Americans are soon to be classified as medical devices, and as such be regulated by U.S. Food and Drug Administration, the agency announced Monday.The new rule does not apply to tests.

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FDA Law Blog: Biosimilars

JANUARY 24, 2024

The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp”—now in its 42nd iteration—is scheduled to take place from March 13-14, 2024, at the SpringHill Suites NY Manhattan Times Square South, New York. Join the “Who’s Who” of the FDA Bar and don’t miss your opportunity to join their ranks! Join our co-chairs Kurt R.

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BioPharma Drive: Drug Pricing

JULY 11, 2023

While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the US regulator in its current review cycle.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). Under the Administrative Procedure Act, FDA is obligated to address major substantive issues when – and not so much if – it publishes a final rule.

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BioPharma Drive: Drug Pricing

AUGUST 25, 2023

market against Biogen’s inflammation-regulating medicine Tysabri. According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S.

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FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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ProRelix Research

AUGUST 13, 2023

Software as a Medical Device (SaMD) refers to a class of medical software intended to be used for medical purposes or that is designed to carry out medical functions without […] The post Software as a Medical Devices (SaMD) and US FDA Guidance for their Clinical Evaluation and Clinical … appeared first on ProRelix Research.

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BioPharma Drive: Drug Pricing

JUNE 28, 2024

Federal courts will no longer have to defer to agency regulations for interpretation of ambiguous statutes, a ruling that could have significant impact on the FDA and CMS.

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