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.” Document all corrective actions and follow-up to ensure sustained compliance. By Sarah Wicks & Anne K. In FY2023, FDA conducted over 1000 inspections under the BIMO program.

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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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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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FDA Law Blog

AUGUST 9, 2021

Circuit , FDA published a Federal Register Notice today (August 9) soliciting comments on its proposed approach to implementing the Court’s interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) distinction between drugs and devices.

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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 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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FDA Law Blog

JANUARY 18, 2022

The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. In brief, such devices can be commercially distributed to the general public for non-medical purposes without FDA regulation (e.g., use in education, construction, art, and jewelry). products intended for medical purposes).

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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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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. Hyman, Phelps & McNamara, P.C. (“HP&M”)

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Regulation Compliance In-Vitro Cosmetics 40

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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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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Compliance Drugs Regulation FDA Approval 52

pharmaphorum

OCTOBER 27, 2022

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. Why is guidance needed? What are the rules on Social Media Influencers and Digital Opinion Leaders? About the authors.

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Life Science Compliance Medicine Regulation 98

FDA Law Blog

NOVEMBER 15, 2022

Claud is a 15-year veteran of the Department of Justice, where most recently he was an Assistant Director of the Consumer Protection Branch overseeing the Corporate Compliance and Policy Unit. He is a frequent public speaker on matters of government enforcement strategies under the FDCA as well as corporate compliance best practices.

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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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Compliance Regulation Cosmetics Manufacturing 52

FDA Law Blog

JANUARY 18, 2022

The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. In brief, such devices can be commercially distributed to the general public for non-medical purposes without FDA regulation (e.g., use in education, construction, art, and jewelry). products intended for medical purposes).

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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). Manager, Regulatory Compliance. FDA Guidance Addresses Real-World Evidence Data Standards. Co-Authors: Bill Stoltman, JD. Jenny Fielder.

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FDA Law Blog

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).

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Regulation Radiology Cosmetics Compliance 59

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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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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Regulation In-Vitro Manufacturing Licensing 81

Cloudbyz

OCTOBER 19, 2023

Regulatory Compliance: Streamlining processes aids in meeting stringent regulatory requirements and maintaining data integrity. Conclusion A unified clinical trial management platform is no longer a luxury but a necessity for pharmaceutical companies aiming to thrive in an increasingly competitive and regulated industry.

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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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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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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

DECEMBER 21, 2023

Those who attended their annual Enforcement, Litigation, and Compliance Conference holiday reception earlier this month got a sneak peek at this new branding effort with the unveiling of the association’s new logo ( here ). 2024 brings a host of Hyman, Phelps & McNamara, P.C. (“HPM”)

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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. Integrated Compliance and Governance With stringent regulations governing clinical trials, compliance is of utmost importance.

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The Pharma Data

DECEMBER 30, 2020

deputy director of the FDA’s Center for Veterinary Medicine (CVM) Division of Compliance: “Although this pet food recall is still unfolding, we are sharing the facts we have so far because the levels of aflatoxin found in the recalled pet food are potentially fatal. SILVER SPRING, Md. , SOURCE U.S. Food and Drug Administration.

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Production Cosmetics Compliance Containment 52

Cloudbyz

MAY 24, 2023

The trials span several categories of consumer products such as cosmetics, personal care products, nutrition supplements, food, beverages, and consumer health products. This includes trial design, participant recruitment, data collection and analysis, and regulatory compliance.

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Clinical Trials Clinical Trials Production Trials 52

FDA Law Blog

MAY 23, 2023

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. Gaulkin & Riëtte van Laack — On May 16, the U.S.

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FDA Law Blog

OCTOBER 6, 2023

The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

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The Pharma Data

APRIL 28, 2022

that are not in compliance with applicable requirements. These proposed regulations do not include a prohibition on individual consumer possession or use. Source link: [link].

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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

The Pharma Data

NOVEMBER 12, 2021

During the examination, the FDA investigator made several compliances that are outlined in an examination bonus report, also known as an “ FDA Form 483.” The FDA investigator handed a list of their compliances to the company. Source link: [link].

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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

APRIL 27, 2022

As we outlined in the Closer to Zero action plan, the agency is increasing targeted compliance activities as part of our efforts to monitor levels of these elements in foods through the FDA’s Total Diet Study , Toxic Elements in Food and Foodware program and sampling assignments,” said Susan Mayne, Ph.D., Source link: [link].

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FDA Law Blog

SEPTEMBER 6, 2023

The Guidance advises that the meeting request not be submitted until “significant progress” toward remediation has been made.

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FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.

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FDA Law Blog

AUGUST 17, 2022

Thus, consumers worried about protections can either shop with a licensed professional or can rely on FTC to enforce its regulations precluding false and misleading advertising and unfair or deceptive business practices. Legally marketed devices that do not need a new 510(k) must comply with these regulations by April 14, 2023.

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