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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XTalks

FEBRUARY 8, 2022

Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? The list includes 30 food safety tasks that fall into several categories, including allergens, cosmetics, dietary supplements, food additives, Food Safety Modernization Act (FSMA), labeling and nutrition.

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Cosmetics Regulation Genome Genomics 97

FDA Law Blog

APRIL 19, 2021

FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device. The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products.

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Camargo

SEPTEMBER 8, 2021

devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”. PANDAs have historically been overseen by the FDA’s Office of Generic Drugs and thus regulated more like a generic than an NDA. Final Regulation Issued for “Intended Use”.

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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). Today, the U.S. Related Information.

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Pharmaceutical Technology

MARCH 30, 2023

The FDA’s proposed FY2024 Budget tops $7bn, to be shared between drug, food, and cosmetics tasks and overheads such as buildings; this is $372m higher than in FY 2023, a 10% increase. Postmarket Safety Collaborative: +$10.1m for a total of $36.8m to enhance the safety surveillance of adverse events. Source: FDA © GlobalData

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Contract Manufacturing Manufacturing Pharma Companies Cosmetics 147

The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. This alert covers FDA-regulated products purchased from Family Dollar stores in those six states from Jan. Recalls, Market Withdrawals & Safety Alerts Report a Problem to the FDA. ###. Today, the U.S.

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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. Additional criteria for the marketing application must be met to obtain the benefits. • Orphan Drug Designation.

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Production Drugs Marketing Regulation 138

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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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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Regulation Genetics Cosmetics Compliance 59

Cloudbyz

MAY 26, 2023

The cosmetics and personal care industry is one where customer trust is paramount, given that the products are applied directly to the skin, hair, and body. These solutions are designed to monitor, detect, evaluate, and prevent any adverse effects associated with the use of a product after it has been released on the market.

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Cosmetics Compliance Branding Production 52

Fossil Remedies

OCTOBER 16, 2022

In a pharma business, you have a distribution network like a pharma manufacturing company, pharma marketing company, C&F agents, wholesalers/distributors/stockiest, retailers, and pharmacies. Every pharma company needs a drug license number to begin distribution, marketing, and manufacturing activities. Manufacturing Drug License.

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Pharma in Brief

JANUARY 10, 2024

However, many details remain to be addressed in forthcoming regulations. CIPO consulted on proposed features of the regulations in 2023 (see here ), including many factors that would reduce the length of the PTA term. Draft regulations are expected to be released for consultation in 2024. The Guidance was last updated in 2005.

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Regulation Drugs Production Medicine 52

FDA Law Blog

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” By Sarah Wicks & Anne K. Ensure all relevant records and data (whether electronic or otherwise) are readily accessible and organized for review.

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FDA Law Blog

JUNE 28, 2023

The proposed legislation appears to be an effort to resolve issues created by FDA’s Center for Veterinary Medicine’s (CVM) interpretation of the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of food. On October 18, 2022, CVM held a virtual listening session on the regulation of animal foods with certain types of claims.

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pharmaphorum

OCTOBER 27, 2022

Websites – Companies can use appropriate search engine optimisation (SEO) and marketing tools to ensure that their websites are displayed high on the list of results for relevant key word searches. Therefore, companies are encouraged to establish a methodology for calculating fair market value rates. Why is guidance needed?

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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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Manufacturing Cosmetics Regulation Containment 105

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.

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Compliance Drugs Regulation FDA Approval 52

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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Development Production Immune Response Licensing 161

pharmaphorum

JULY 27, 2021

Illinois-headquartered Apar – which makes inhalers, syringe components, eye drop bottles and other delivery systems for pharmaceuticals, cosmetics and other sectors – is paying €8.70 per share in the initial deal, which will give it a 64.6% stake in the company. The deal values Voluntis at around $79 million (around $95 million).

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XTalks

JANUARY 19, 2021

This includes some flavored e-cigarettes imported to the US that do not meet Federal Food, Drug and Cosmetic Act (FD&C Act) requirements, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). In the 2020 fiscal year, CBP seized 93,590 units of e-cigarettes that did not meet US federal regulations.

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Production Cosmetics Marketing Branding 98

FDA Law Blog

DECEMBER 21, 2023

In an interview with the Blog , FDLI wants to recognize the efforts of Chris Perkins, Gabe Lindman and Emma Dardis of Washington, DC-based marketing agency Model B, for their amazing work. 2024 brings a host of Hyman, Phelps & McNamara, P.C. (“HPM”) Plus, the burgundy was kicked up a notch to a cherry red.

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Branding Compliance Regulation Cosmetics 59

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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Manufacturing Production Drugs FDA Compliance 59

FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise).

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Marketing Production FDA Approval Cosmetics 59

The Pharma Data

NOVEMBER 6, 2020

Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). . SILVER SPRING, Md. , .

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FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. FDORA added section 515C, “Predetermined Change Control Plans for Devices” to the Federal Food, Drug, and Cosmetic (FD&C) Act. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g.,

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Manufacturing Marketing Regulation Cosmetics 98

FDA Law Blog

MARCH 20, 2022

Baumhardt, Senior Medical Device Regulation Expert & Anne K. The Guidance applies to voluntary recalls of any food, drug intended for human and animal use, any cosmetic, biological, and tobacco product intended for human use, and any item subject to a quarantine regulation under 21 CFR part 1240. By Philip Won & Lisa M.

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Production Regulation Cosmetics Manufacturing 40

FDA Law Blog

JULY 7, 2021

The use of GEDs by JRC is subject to extensive regulation by Massachusetts, including the need for a judge to authorize the treatment for any patient. That means that the FDA may not enact the regulation at issue before us. FDA cleared 510(k)s for GEDs in the 1990s.

Medicine 52

Medicine Regulation Cosmetics Marketing 52

XTalks

OCTOBER 8, 2020

Markets are increasingly in need of advanced artificial intelligence, flexible IoT data acquisition, compliant data lakes, deep learning and other industrial-grade technologies. Related: AI Algorithm Qualification. This is a symbol of change, not a change of symbol. Aizon’s AI Consulting.

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Manufacturing Life Science Cosmetics Regulation 98

The Pharma Data

NOVEMBER 21, 2021

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. A condition of this accelerated approval is a post-marketing study that will assess final adult height. Related Information.

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FDA Approval Drugs Regulation Genetics 52

FDA Law Blog

APRIL 21, 2024

Since the PTE statute was created with the September 1984 enactment of the Hatch-Waxman Amendments, and even post-AIA, there have been various instances in which FDA-regulated companies (or their counsel) have failed to timely submit a PTE application to the PTO within the statutory 60-day window ( see, e.g. , here ).

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Production FDA Approval Marketing Cosmetics 59

XTalks

NOVEMBER 24, 2022

According to the warning letters, these products are considered adulterated under “section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. have dipped their toes into the hemp product market with various CBD-infused food and beverage products. 331(ll) and 331(a).”.

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Production Branding Cosmetics Marketing 52

FDA Law Blog

JUNE 2, 2022

Since 1984, generic drugs have been approved under ANDAs pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA); before 1984, no formal mechanism for an ANDA existed so FDA used sections 505(b) and 505(c) to approve follow-on drugs based on the Agency’s previous findings of safety and efficacy.

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Drugs Production Cosmetics Generic Drugs 52

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 Manufacturing Regulation Drugs 52

FDA Law Blog

OCTOBER 25, 2021

Shapiro — After 23 years, de novo classification review finally has an implementing regulation ! The other major review processes have had their regulations in place for many decades. Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Part 807, Subpart E).

Regulation 52

Regulation Manufacturing Cosmetics Compliance 52

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. Time to Market: Consumer products operate in a highly competitive market where time is of the essence.

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FDA Law Blog

DECEMBER 22, 2022

FDA , which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. This provision represents a complete shift in the way FDA is allowed to regulate products.

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