Cloudbyz

MAY 24, 2023

This is where unified clinical trial management solutions come into the picture, enhancing efficiency, reducing time to market, and ensuring high-quality, scientifically validated consumer products. A delay in trials or approval can significantly impact the product’s success and the company’s bottom line.

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pharmaphorum

SEPTEMBER 29, 2022

Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. If an mHealth device is life sustaining, then the FDA is certainly going to regulate the device.

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Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. Expanded access to experimental biologics. BLA process (CBER).

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pharmaphorum

OCTOBER 4, 2022

Criteria for regulation. The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). peer-reviewed clinical studies or clinical practice guidelines) meet Criterion 2 and are not medical devices subject to FDA regulation and oversight.

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FDA Law Blog

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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FDA Law Blog

MAY 3, 2021

On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 U.S.C. §

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Advarra

SEPTEMBER 8, 2022

As electronic documentation usage increases in clinical trials, organizations must make sure they’re still protecting participants’ health and safety without sacrificing quality or efficacy. One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations.

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Cloudbyz

AUGUST 9, 2023

As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. Let’s delve into why this method is paramount for the transformation of clinical research management.

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The Pharma Data

MAY 17, 2021

Conducting clinical trials to see if a drug is safe and effective can be a very time-consuming process. To meet the urgent demand for effective therapies, FDA has worked with clinical trial experts to rapidly advance best practices in the design and execution of clinical trials. Source link.

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XTalks

JANUARY 12, 2021

The letter , which was sent on January 4, 2021, stated that several of the company’s products violated section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a) which prohibits the introduction and delivery of new drugs without the Secretary of Health of Human Service’s approval.

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Velocity Clinical Research

JUNE 29, 2023

And if you don’t have the infrastructure and [a team adequately equipped] to run trials, it really is difficult to maintain doing trials.” Dr. Eder practices at Velocity’s research site in Binghamton that partners with United Health Services (UHS) to conduct clinical trials for a broad range of investigational products.

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FDA Law Blog

MAY 3, 2021

Butler — On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 U.S.C. §

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FDA Law Blog

JANUARY 7, 2024

A PMR is a study “that sponsors are required to conduct under one or more statutes or regulations,” whereas a PMC is a study “that a sponsor has agreed to conduct, but that are not required by a statute or regulation” (see FDA Webpage, Postmarketing Requirements and Commitments: Introduction ).

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FDA Law Blog

JANUARY 1, 2024

Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators. Patcos Cosmetics Pvt. If FDA wanted to create that impression, it likely succeeded. They have great impact on most companies that receive them.

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The Pharma Data

APRIL 26, 2022

Given the similar course of COVID-19 disease in adults and pediatric patients, today’s approval of Veklury in certain pediatric patients is supported by efficacy results from phase 3 clinical trials in adults. Information on the trials in adults can be found in the FDA-approved drug labeling for Veklury. Source link: [link].

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FDA Law Blog

OCTOBER 7, 2024

At the time we posted about the Jarkesy decision, we predicted that it would impact FDA-regulated industry: The impact on FDA matters could be significant. The Court reasoned that the SEC’s civil penalties “are designed to punish and deter, not compensate,” and that they are a remedy “that could only be enforced in courts of law.”

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The Pharma Data

FEBRUARY 13, 2022

As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA Law Blog

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). at 50,040 codified at 21 C.F.R.

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FDA Law Blog

OCTOBER 11, 2022

We use the term “confirmatory evidence” as short-hand for one of the two ways explicitly defined in the Federal Food Drug & Cosmetic Act (“FD&C Act”) for demonstrating substantial evidence of effectiveness. Here, FDA cited to survival data from the same clinical trial population as confirmatory evidence.

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XTalks

JANUARY 25, 2023

Brenzavvy’s approval was based on an impressive amount of data collected from 23 clinical trials involving over 5,000 patients with type 2 diabetes. The Federal Food, Drug, and Cosmetic Act (FFDCA) gives the FDA the legal authority to approve drugs for both humans and animals.

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XTalks

FEBRUARY 8, 2021

While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023. The regulator allows biosimilars to show slight differences in clinically inactive components of a product.

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FDA Law Blog

AUGUST 16, 2021

A PANDA, or the Pre-Hatch-Waxman Abbreviated New Drug Application, refers to abbreviated drug applications submitted and approved under sections 505(b) and 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA) prior to the enactment of the Hatch-Waxman Amendments in 1984, as FDA announced in the Federal Register last week.

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Pfizer

DECEMBER 13, 2022

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act, unless the authorization is terminated or revoked sooner. There are limited clinical data available for PAXLOVID. Herbal Products: St.

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The Pharma Data

DECEMBER 18, 2020

effective in preventing COVID-19 disease among these clinical trial participants with 11 cases of COVID-19 in the vaccine group and 185 in the placebo group. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The vaccine was 94.1%

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Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines.

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The Pharma Data

NOVEMBER 21, 2020

In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. View original content to download multimedia: [link].

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The Pharma Data

NOVEMBER 6, 2020

. This device was studied in a 30-day randomized, sham-controlled trial of 70 patients. A sham therapy is an inactive treatment or procedure that is intended to mimic as closely as possible a therapy in a clinical trial. Patients in the sham group wore the device, but no vibratory stimulation was provided.

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The Pharma Data

FEBRUARY 13, 2022

The EUA for bebtelovimab is supported by clinical and nonclinical data. The clinical data are from a phase 2, randomized, single-dose clinical trial evaluating the efficacy of bebtelovimab alone and bebtelovimab combined with other monoclonal antibodies for treating mild to moderate COVID-19. Source link: [link].

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The Pharma Data

FEBRUARY 4, 2021

– Full-Year Global Net Revenues from the Aesthetics Portfolio Were $2.590 Billion; Global Botox Cosmetic Net Revenues Were $1.112 Billion. Global Botox Cosmetic net revenues were $493 million , an increase of 9.1 – Reports Fourth-Quarter Diluted EPS of $0.01 percent on a reported basis, or 45.0 Recorded a $4.7

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FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. As part of the Accelerated Approval, Oncopeptides was required to conduct “further adequate and well-controlled clinical trials to verify and describe clinical benefit.” That did not happen.

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Pfizer

DECEMBER 20, 2022

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act, unless the authorization is terminated or revoked sooner. There are limited clinical data available for PAXLOVID. Herbal Products: St.

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XTalks

AUGUST 2, 2023

In September 2022, Roche acquired Good Therapeutics for an upfront payment of $250 million, and has access to their PD-1-regulated IL-2 program. 2) Botox Therapeutic/Cosmetic Botox, or botulinum neurotoxin, is a neurotoxic protein produced by the Clostridium botulinum bacteria. in January 2023, according to the manufacturer.

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Pfizer

NOVEMBER 23, 2022

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner. There are limited clinical data available for PAXLOVID. Herbal Products: St.

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FDA Law Blog

JUNE 2, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Office of Women’s Health (OWH) recently celebrated its 30th anniversary. This office was formed in 1994 to promote the inclusion of women in clinical trials and to provide leadership on topics related to the health of women.

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The Pharma Data

FEBRUARY 23, 2022

The safety and efficacy of the One Male Condom was studied in a clinical trial comprised of 252 men who have sex with men and 252 men who have sex with women. When used during anal intercourse, the One Male Condom should be used with a condom-compatible lubricant. All participants were between 18 through 54 years old.

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The Pharma Data

DECEMBER 31, 2020

Purdue pleaded guilty to one count of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two counts of conspiracy to violate the Federal Anti-Kickback Statute.

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FDA Law Blog

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF).

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