FDA Law Blog

JUNE 14, 2021

Shapiro — In our last post on Laboratory Developed Tests (LDTs) , we suggested that Congress, not FDA, should lead in directing modernization of LDT regulation. This step would help propel forward a public conversation (which CMS has already started ) about how to update these regulations in light of technological advances.

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Regulation Development Cosmetics In-Vitro 92

FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

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Regulation Production Cosmetics Sales 44

The Pharma Data

MARCH 29, 2022

an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Food and Drug Administration (FDA) announced today that Bravo Packing, Inc., Related Information.

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Manufacturing Contamination Cosmetics Regulation 52

FDA Law Blog

MARCH 6, 2022

Mullen — On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR). ISO 13485, while largely duplicative to the QSR, is not a perfect fit with other existing FDA regulations.

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Regulation Compliance Manufacturing Packaging 52

Pharma Tutor

FEBRUARY 2, 2023

FDA Inspections - Overview admin Thu, 02/02/2023 - 13:52 FDA Inspection is a regulatory process conducted by the United States Food and Drug Administration (FDA) to evaluate the compliance of food and drug establishments with FDA regulations and standards.

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Cosmetics Compliance Regulation Manufacturing 52

FDA Law Blog

MARCH 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Section 3309 of the Food and Drug Omnibus Reform Act (FDORA), signed into law on December 29, 2022, amended section 738(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding clause (ii) “Small business fee waiver.”

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Manufacturing Sales Cosmetics Regulation 62

FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. We are not aware of a similar guidance for meeting requests from manufacturers of NDA drugs.

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Generic Drugs Manufacturing Drugs Cosmetics 44

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 provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.

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Regulation Compliance In-Vitro Cosmetics 40

FDA Law Blog

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Revised § 820.3

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Regulation Manufacturing Packaging Packaging 57

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 104

FDA Law Blog

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.

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Cosmetics Compliance Generic Drugs Regulation 57

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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In-Vitro Regulation Manufacturing Licensing 80

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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Regulation Production Drugs In-Vitro 40

FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

Manufacturing 98

Manufacturing Regulation Compliance Production 98

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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Development Regulation Production Drugs 186

XTalks

MARCH 21, 2024

This effort also supports quality manufacturing across the pharmaceutical industry. An additional $8 million is allocated for the Modernization of Cosmetics Regulation Act (MoCRA), which aims to enhance cosmetic product safety. Modernization and Mission Support The FDA food budget proposes $114.8

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Cosmetics Production Regulation Manufacturing 52

Fossil Remedies

OCTOBER 16, 2022

The next important consideration is a proper distribution channel from the manufacturer to end customers. 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. Manufacturing Drug License.

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Licensing Licensing Pharma Companies Manufacturing 52

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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Compliance Regulation Cosmetics Manufacturing 52

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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FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

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Manufacturing Regulation Compliance Production 75

Camargo

NOVEMBER 15, 2021

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). FDA Publishes ICH Guidelines on Continuous Manufacturing. FDA Guidance Addresses Real-World Evidence Data Standards.

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Development Manufacturing Production Packaging 187

XTalks

SEPTEMBER 17, 2020

The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. FDA Chief Counsel Stacy Amin said in a statement , “Manufacturing foods in violation of the Produce Safety Rule and Current Good Manufacturing Practice regulations places consumers’ health at risk.

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Production Contamination Cosmetics Bacteria 98

XTalks

OCTOBER 8, 2020

Aizon is well positioned to help those manufacturing sectors meet stringent regulatory requirements and extract deeper understanding of complex processes, which ultimately leads to new sources of value,” said John Vitalie, chief executive officer of Aizon, in the press statement from the company. Aizon’s AI Consulting.

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Manufacturing Life Science Cosmetics Regulation 98

XTalks

APRIL 14, 2023

Last week, the EPA issued a set of proposed rules targeting emission levels at facilities that manufacture ethylene oxide. These regulations are long overdue, by almost a decade. The rules include more stringent regulations that include fenceline monitoring for pollutants from chemical-emitting plants.

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Regulation Scientist Manufacturing Cosmetics 81

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. In 1997, FDA released regulations providing guidance on the use of electronic systems. Un-specified identified Agency regulations. There are many factors in how Part 11 regulations affect software.

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Compliance Regulation Packaging Packaging 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 Drugs Regulation 52

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. Manufacturers should be able to verify and validate the proposed modifications within their existing quality system.

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Manufacturing Marketing Regulation Cosmetics 98

FDA Law Blog

MAY 23, 2023

Specifically, field staff are advised to pay close attention to situations where allergen cross-contact may occur because of poor current good manufacturing practices (cGMPs), inadequate preventive controls, or inadequate controls under the juice or seafood HACCP regulations.

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Containment Contamination Manufacturing Compliance 44

FDA Law Blog

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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Production Cosmetics Manufacturing Licensing 57

Pharmacy Checkers

JUNE 26, 2020

These drug regulators have engaged in regular consultations since 2003 in order to share insights and best practices. can rely on EU inspections of drug manufacturing establishments in any EU country. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Due to an MRA between the FDA and EMA, the U.S. Current U.S.

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FDA Law Blog

MAY 17, 2021

In particular, these members of Congress seem to be requesting that HHS revive a dysfunctional (and probably unconstitutional ) approach to regulation of LDTs. Given this stated concern about test accuracy and validation, why are they only urging FDA to regulate COVID?19 FDA has not followed that procedure for LDTs.

Development 52

Development Cosmetics Regulation In-Vitro 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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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).

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Regulation Manufacturing Cosmetics Compliance 52

XTalks

NOVEMBER 28, 2023

In the US, the regulation of food products, including the ban on certain items, falls primarily under the jurisdiction of two key agencies: the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA). In response, a modified version called Kinder Joy has been introduced, adhering to FDA regulations.

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Regulation Sales Containment Production 52

The Pharma Data

APRIL 28, 2022

If these proposed rules are finalized and implemented, FDA enforcement will only address manufacturers, distributors, wholesalers, importers and retailers who manufacture, distribute, or sell such products within the U.S. These proposed regulations do not include a prohibition on individual consumer possession or use.

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Production Cosmetics Regulation Manufacturing 52

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. Companies should monitor, moderate and, where appropriate, delete inappropriate comments in a timely manner.

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Life Science Compliance Medicine Regulation 96

FDA Law Blog

MAY 17, 2021

In particular, these members of Congress seem to be requesting that HHS revive a dysfunctional (and probably unconstitutional ) approach to regulation of LDTs. Given this stated concern about test accuracy and validation, why are they only urging FDA to regulate COVID?19 FDA has not followed that procedure for LDTs.

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Development Cosmetics Regulation In-Vitro 40