Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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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. While Part 11 is widely known, this blog explains how it fits in with your research software. In 1997, FDA released regulations providing guidance on the use of electronic systems.

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FDA Law Blog

DECEMBER 6, 2023

filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.

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FDA Law Blog

MARCH 24, 2024

Field preemption applies when federal regulation occupies the regulated area so pervasively that it leaves no room for states to supplement it, even if the state law is consistent with the federal law. The court also noted that the practice of pharmacy is an area traditionally left to state regulation.

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Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act. BLA process (CBER).

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FDA Law Blog

NOVEMBER 6, 2023

The LMG awards are reflective of HPM’s excellence across several of our core life sciences practices, from controlled substances work to drug development, to Hatch-Waxman, to drug pricing, to medical device regulation. Research for the guide was based on 1,000s of interviews and surveys completed by law firm partners active in the market.

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XTalks

APRIL 14, 2023

These regulations are long overdue, by almost a decade. If enacted, these updated regulations would reduce emissions in fenceline communities,” said Darya Minovi, a senior researcher scientist at the Union of Concerned Scientists, in a CNN report.

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pharmaphorum

OCTOBER 27, 2022

Discussion Forums – If discussion forums are hosted or facilitated by a company, the company should be confident it can moderate the forum such that the content complies with relevant regulations, laws, and codes. Why is guidance needed? What are the rules on Social Media Influencers and Digital Opinion Leaders?

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XTalks

APRIL 14, 2021

New research published in Science Advances has suggested that a natural cyan blue extracted from red cabbage could replace synthetic blue dyes in food. Food coloring is an essential part of the food and beverage industry; however, some research suggests that using synthetic dyes is not healthy for the consumer. 1, FD&C Blue No.

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The Pharma Data

NOVEMBER 21, 2021

director of the Division of General Endocrinology in the FDA’s Center for Drug Evaluation and Research. People with achondroplasia have a genetic mutation that causes a certain growth regulation gene called fibroblast growth factor receptor 3 to be overly active, which prevents normal bone growth. Source link: [link].

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pharmaphorum

JULY 16, 2021

A drug caused amantadine that down-regulates glutamate – which opposes dopamine’s effects in the brain – is already used to treat dyskinesias but can cause side effects including fainting, dizziness, and hallucinations. Ipsen’s other main research areas are oncology and rare diseases.

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Camargo

JANUARY 27, 2021

Where is the regulation found? 21 Code of Federal Regulations (CFR) §316 ; Orphan Drug Act. Section 529 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)/ 21 United States Code (USC) §360ff. Potential Pediatric Research Equity Act (PREA) requirements exemption. Orphan Drug Designation. 21 CFR §814 Subpart H.

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FDA Law Blog

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.

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XTalks

JANUARY 18, 2021

Every other month, the US Food and Drug Administration (FDA) hosts a webinar to highlight ongoing research and innovation underway across all of the agency’s branches and the role it plays in advancing public health. Harris explained CORE’s process of identifying an outbreak, starting with its Signals and Surveillance Team.

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FDA Law Blog

MAY 23, 2023

Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021). Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact.

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XTalks

SEPTEMBER 28, 2023

This is because the US has more lenient food ingredient regulations, potentially exposing consumers to carcinogens and harmful chemicals. Most research, however, suggests that the amount of titanium dioxide ingested from food is minimal, posing little to no risk to human health.

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The Pharma Data

MARCH 21, 2022

director of the FDA’s Center for Biologics Evaluation and Research. 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. Source link: [link].

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The Pharma Data

APRIL 7, 2023

It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes—particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” said FDA Commissioner Robert M.

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FDA Law Blog

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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The Pharma Data

NOVEMBER 23, 2021

director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. In the study, 352 transplant recipients with CMV infections who did not respond (with or without resistance) to treatment randomly received Livtencity or treatment assigned by a researcher for up to eight weeks. Source link: [link].

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Cloudbyz

OCTOBER 19, 2023

Enhanced Collaboration: A unified platform fosters better communication and collaboration among research teams, sponsors, investigators, and other stakeholders. This blog explores 25 compelling reasons why pharmaceutical companies should adopt such a platform to streamline their clinical trial operations.

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The Pharma Data

FEBRUARY 24, 2022

Director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. 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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The Pharma Data

NOVEMBER 29, 2021

deputy director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research. “By 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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The Pharma Data

APRIL 29, 2022

director of the Center for Biologics Evaluation and Research. “We 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. Source link: [link].

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The Pharma Data

MAY 17, 2021

Master protocols that are well designed and executed can accelerate drug development by maximizing the amount of information obtained from the research effort. These trials can be updated to incorporate new scientific information, as medical science advances. Content current as of: 05/17/2021. Source link.

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Advarra

JULY 19, 2022

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. The sponsor is the pharmaceutical company conducting the trial.

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The Pharma Data

FEBRUARY 13, 2022

director of the FDA’s Center for Drug Evaluation and Research. 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. Source link: [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. § Some examples include: “[A]ntiviral, ongoing clinical research on effectiveness against COVID-19”. “4-Thieves W]anted to share my COVID story. [t]here

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The Pharma Data

MARCH 15, 2022

director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research. 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. Source link: [link] ov/.

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Velocity Clinical Research

JUNE 29, 2023

With nearly three decades as a family physician and almost 25 years as a Principal Investigator (PI), Frank Eder, MD, believes two primary elements are critical for sustained success in clinical research. “You must have a true interest in the research side of it. But passion alone isn’t enough. and Canada.

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The Pharma Data

MAY 5, 2022

director of the FDA’s Center for Biologics Evaluation and Research. 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. Source link: [link].

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XTalks

MARCH 25, 2024

They work by mimicking the action of the naturally occurring hormone GLP-1, which is involved in regulating blood sugar and appetite. In a controversial decision, the medication’s use was expanded to adolescents, which is a concern since research suggests the drugs must be taken for life in order to maintain results.

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XTalks

FEBRUARY 26, 2021

Despite victories in civil rights for Black people in the 1960s, research shows that even today, people of minority backgrounds still face discrimination in some areas of society, including in hiring processes. Pammel at the Iowa State Experimental Station, continuing his research on plant diseases. Washington.

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The Pharma Data

DECEMBER 13, 2020

Our Veterinary Innovation Program focuses on providing greater certainty in the regulatory process, encouraging development and research of innovative public health products, as well as supporting an efficient and predictable pathway to the approval of IGAs in animals,” said Steven M. Solomon , D.V.M., .

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FDA Law Blog

OCTOBER 17, 2021

The final administrative orders include the same citations to the relevant Federal Register notices that have always been found in the Code of Federal Regulations, but no links. Even taking into consideration the webpage’s well-known shortcomings that resulted from a lack of funding for its upkeep over the years, it is a handy research tool.

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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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FDA Law Blog

APRIL 26, 2021

On Friday April 23, President Biden signed into law the Food Allergy Safety, Treatment, Education and Research (FASTER) Act that designates sesame as the ninth major food allergen. By Karin F.R. Moore & Riëtte van Laack —. Then in 2019 Illinois enacted a law that required sesame allergen labeling.

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