FDA Law Blog

JULY 8, 2021

Javitt — For many years, one of the most controversial topics in device regulation has been the dual-track oversight of in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). At various points and in various ways, FDA has sought – mostly unsuccessfully – to regulate LDTs (see here ).

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FDA Law Blog

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters. In the pre-market area, Ms. In addition, Ms.

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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

MARCH 25, 2024

The latest phase of Oprah’s weight loss journey brought her to GLP-1 receptor agonist drugs, which have taken Hollywood and social media by storm. GLP-1 receptor agonists, a class of drugs initially developed to treat type 2 diabetes, have been found to have significant effects on weight loss.

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Pharma in Brief

JANUARY 10, 2024

As you start the new year, allow us to recap 2023’s important legal and regulatory developments for Canadian pharma. The most significant legal development in 2023 was the introduction of a system of patent term adjustment ( PTA ). However, many details remain to be addressed in forthcoming regulations. PMPRB in flux.

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FDA Law Blog

SEPTEMBER 30, 2021

See Federal Food, Drug, and Cosmetic Act (“FDCA”) Section 503A(b)(2). The matter involves a “decades old skirmish” dating back to the late 1990s, (and previously blogged about here and here ) when Congress passed the Food and Drug Administration Modernization Act (“FDAMA”), which created Section 503A.

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FDA Law Blog

JUNE 28, 2023

This legislation, named the Innovative Feed Enhancement and Economic Development Act (Innovative FEED Act) , is an effort to create an approval process for ingredients with environmental or food safety claims as food additives rather than as animal drugs. 1844 – Animal Drug and Animal Generic Drug User Fee Amendments of 2023.

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Camargo

JANUARY 27, 2021

Comparing Orphan Drug, Rare Pediatric Disease, and Humanitarian Use Device Designations. Orphan Drug Designation. 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.

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The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration took new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and preventing new addiction. director of the FDA’s Center for Drug Evaluation and Research. Today, the U.S. Source link: [link].

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FDA Law Blog

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. For many drugs, both a registry and an outcomes study are required.

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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. is the largest dedicated food and drug law firm in the country.

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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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The Pharma Data

NOVEMBER 21, 2021

Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older with achondroplasia and open epiphyses (growth plates), meaning these children still have the potential to grow. director of the Division of General Endocrinology in the FDA’s Center for Drug Evaluation and Research.

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FDA Law Blog

JULY 13, 2021

With the approach of the January 1, 2022 mandatory compliance deadline for the BE standard, manufacturers and importers of food and dietary supplements should work to develop strategies for compliance and evaluating each product’s bioengineered (BE) status if they have not already done so.

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pharmaphorum

JULY 27, 2021

Drug delivery specialist Aptar Group has agreed a deal to take a near two-thirds share in Voluntis, a French developer of digital therapeutics (DTx), with a view to taking full control of the company later this year. per share in the initial deal, which will give it a 64.6% stake in the company. stake in the company.

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FDA Law Blog

MAY 6, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. are cybersecure.

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FDA Law Blog

DECEMBER 21, 2023

This dinner—at the Waldorf Astoria in DC—will commemorate FDLI’s role during key eras in food and drug law and will have fun surprises as well!” Mark your calendars now. Little known holiday fact: The story of Rudolph was originally written in 1939 by Robert May as a booklet for Montgomery Ward, a department store.

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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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The Pharma Data

NOVEMBER 23, 2021

director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern. Approval is for Cytomegalovirus, a Type of Herpes Virus. Today, the U.S. Source link: [link].

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pharmaphorum

JULY 16, 2021

The deal gives Ipsen worldwide rights to the mid-stage drug – called mesdopetam – and puts the company on the hook for another $335 million in development, regulatory and sales milestones. The drug has since been discontinued. Servier has since stepped in as the partner for that project, which remains in preclinical development.

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FDA Law Blog

JUNE 19, 2023

Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. Over the years we have blogged many times on the twists and turns of the efforts to regulate LDTs. And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds.

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Cloudbyz

OCTOBER 19, 2023

The pharmaceutical industry plays a critical role in improving healthcare by developing and bringing new medicines to market. Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount.

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FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. FDA-2021-N-1272) to inform future policy development. products intended for medical purposes).

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

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The Pharma Data

JUNE 2, 2022

Food and Drug Administration launched a new initiative, Supplement Your Knowledge , to help educate, inform, and broaden consumer, educator and healthcare professional understanding of dietary supplements. Today, the U.S. More than half of all Americans take dietary supplements daily or on occasion. Source link: [link].

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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. Today, we’re providing industry guidance for creating master protocols (an overarching protocol designed to answer multiple questions) when evaluating drugs for the treatment or prevention of COVID-19.

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The Pharma Data

APRIL 7, 2023

Food and Drug Administration announced the final decision to withdraw approval of Makena—a drug that had been approved under the accelerated approval pathway. This drug was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. Today, the U.S.

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FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. FDA-2021-N-1272) to inform future policy development. products intended for medical purposes).

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The Pharma Data

APRIL 28, 2022

Food and Drug Administration is announcing proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in cigars. These proposed regulations do not include a prohibition on individual consumer possession or use. Today, the U.S.

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The Pharma Data

MARCH 7, 2022

Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). “It Today, the U.S.

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The Pharma Data

MARCH 21, 2022

Food and Drug Administration is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Wed., Today, the U.S. Timing and populations for COVID-19 vaccine booster doses in the coming months. Source link: [link].

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The Pharma Data

DECEMBER 4, 2020

Food and Drug Administration (FDA) authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). This is another example of the FDA working with test developers to bring important diagnostics to Americans,” said FDA Commissioner Stephen M. .

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The Pharma Data

FEBRUARY 24, 2022

Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. Today, the U.S. Related Information. The FDA, an agency within the U.S.

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XTalks

APRIL 14, 2021

The color cyan blue is not easy to find in nature, making this discovery significant for the industry’s innovation and developments. Scientists used synthetic biology and computational protein design tools to develop an enzymatic process to transform red cabbage anthocyanins into their desired color. 1, FD&C Blue No.

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The Pharma Data

DECEMBER 30, 2020

We are working quickly on this developing situation and will continue to update the public as new information becomes available. 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

MAY 3, 2021

for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). 42 C.F.R. §§ 11.10, 11.44(a).

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The Pharma Data

APRIL 15, 2022

Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. Today, the U.S. director of the FDA’s Center for Devices and Radiological Health. for the next public health emergency.”.

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