Cloudbyz

OCTOBER 19, 2023

Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount. In recent years, the need for a unified clinical trial management platform has become increasingly evident. Cost Efficiency: Centralized data management reduces administrative overhead, minimizing trial costs.

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pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.

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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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Cloudbyz

MAY 24, 2023

The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis. Consumer product clinical trials typically involve the evaluation of new formulations or ingredients for safety, efficacy, and user acceptability.

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pharmaphorum

JULY 16, 2021

Mesdopetam is currently in a phase 2b trial as a potential treatment option for people living with Parkinson’s who have uncontrolled involuntary movements (dyskinesias) caused by treatment with levodopa, the standard therapy for the disorder. Ipsen’s other main research areas are oncology and rare diseases.

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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

NOVEMBER 15, 2022

At DOJ, Mr. Claud prosecuted and supervised complex criminal and civil trial litigation and investigations under the Food, Drug, and Cosmetic Act, Federal Trade Commission Act, Consumer Product Safety Act, and Federal data privacy laws.

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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. The short answer: No.

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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 C.F.R. §§ 11.10, 11.44(a).

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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. Content current as of: 05/17/2021.

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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. Unified Data Management Clinical trials generate vast amounts of data, from patient records to lab results and monitoring findings.

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FDA Law Blog

OCTOBER 7, 2024

Constitution’s Seventh Amendment right to a jury trial. 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. Bringing an administrative claim is typically much less demanding in time and resources than litigating a jury trial.

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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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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

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

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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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

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. 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.

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The Pharma Data

FEBRUARY 24, 2022

For today’s approval, Jardiance’s safety and effectiveness were evaluated as an adjunct to standard of care therapy in a randomized, double-blind, international trial comparing 2,997 participants who received Jardiance, 10 mg, once daily to 2,991 participants who received the placebo. Source link: [link].

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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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Hormones Drugs Manufacturing Regulation 52

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

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. Rather, confirmatory evidence can be a means to substantiate the effects observed in a single pivotal trial.

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The Pharma Data

NOVEMBER 23, 2021

Livtencity’s safety and efficacy were evaluated in a Phase 3, multicenter, open-label, active-controlled trial that compared Livtencity with a treatment assigned by a researcher running the study, which could include one or two of the following antivirals used to treat CMV: ganciclovir, valganciclovir, foscarnet or cidofovir.

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FDA Law Blog

JUNE 12, 2022

In that case, the DOJ filed a statement of interest , arguing that a violation of the Federal Food, Drug, and Cosmetic Act (FDCA) or implementing regulations may sometimes be “material to the government’s decision whether to pay for the affected product, and thus relevant in an FCA case.”.

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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. Also consider CRO oversight, trial management, data handling and record keeping, as well as allocation of responsibilities.

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Packaging Packaging Drugs Containment 52

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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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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FDA Approval Drugs Life Science Cosmetics 52

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. IMPORTANT SAFETY INFORMATION . Antimycobacterials: rifampin. Herbal Products: St.

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The Pharma Data

FEBRUARY 13, 2022

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. The placebo-controlled portion of the trial enrolled 380 low-risk patients (i.e., 2 omicron subvariant.

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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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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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FDA Law Blog

OCTOBER 2, 2023

Since 1962, the Federal Food Drug & Cosmetic Act (FDC Act) has given FDA authority to reject a drug application that fails to provide substantial evidence of effectiveness. the single trial) is and (2) how robust and convincing the confirmatory evidence is. the single trial) and secondary evidence (i.e.,

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Pfizer

AUGUST 15, 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. IMPORTANT SAFETY INFORMATION. Anticonvulsant: carbamazepine, primidone, phenytoin.

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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. Nightware is available by prescription only and is intended for home use. .

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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% SOURCE U.S.

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The Pharma Data

NOVEMBER 12, 2021

The effectiveness and safety of Besremi were evaluated in a multicenter, single-arm trial that lasted 7.5 In this trial, 51 adults with polycythemia vera received Besremi for an average of about five years. Source link: [link].

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