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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Clinical Trial Podcast

JULY 31, 2022

He is currently the Principal Attorney of Kulkarni Law Firm where he focuses his practice on providing healthcare companies with legal, compliance, and regulatory advice. Darshan is a regulatory attorney specializing in FDA law, professor, author, and speaker.

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Cloudbyz

FEBRUARY 29, 2024

Rapid Identification of Safety Signals : Timely detection of safety signals is imperative for ensuring patient safety and regulatory compliance in clinical trials. Optimization of Regulatory Reporting : Compliance with regulatory requirements is a cornerstone of pharmacovigilance activities in clinical trials.

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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. Global Regulatory Compliance Safety vigilance solutions can be tailored to meet the specific regulatory requirements of different countries.

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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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FDA Law Blog

NOVEMBER 16, 2021

Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters. She has also held positions in regulatory affairs, clinical affairs, quality assurance, and compliance at Mallinckrodt Pharmaceuticals, GE Healthcare, and Abbott Laboratories. In the post-market area, Ms.

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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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FDA Law Blog

MARCH 24, 2024

PhRMA argued that Congress established the 340B drug discount program, imposed ceilings on prices drugmakers may charge certain healthcare facilities, specified what those facilities are, and provided compliance and enforcement mechanisms for manufacturers and covered entities. As such, the court held that FDCA does not preempt Act 1103.

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Cloudbyz

AUGUST 9, 2023

Integrated Compliance and Governance With stringent regulations governing clinical trials, compliance is of utmost importance. A unified platform can incorporate compliance guidelines and ensure that all processes align with regulatory standards.

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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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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. About the authors.

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FDA Law Blog

NOVEMBER 6, 2023

Our knowledge of the laws and regulations governing drugs, medical devices, foods, dietary supplements, and cosmetics is unparalleled in breadth and depth. Due to our broad bench of expertise, the firm is well equipped to defend companies against government enforcement actions and advise clients on necessary compliance efforts.

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

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FDA Law Blog

JANUARY 18, 2022

a traditional manufacturing site vs. the point of care); The capabilities available at a point-of-care healthcare facility can help mitigate production risks; Entities involved in 3D printing of devices should understand their regulatory responsibilities under the Federal Food, Drug, and Cosmetic Act; and.

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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., Source link: [link].

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Pharma in Brief

JANUARY 7, 2024

Section 804 Importation Programs On October 1, 2020, the FDA published a rule entitled Importation of Prescription Drugs (the US Importation Rule ) to implement Section 804 of the Food, Drug, and Cosmetic Act.

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The Pharma Data

NOVEMBER 30, 2020

Federal Food, Drug, and Cosmetic Act permits the FDA to approve a New Drug Application (NDA) in part on the basis of published literature and/or a previous agency finding as to the safety or effectiveness of a drug. ” About the 505(b)(2) Pathway. Section 505(b)(2) of the U.S. TearClear is based in Boston, MA.

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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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pharmaphorum

SEPTEMBER 29, 2022

Kyle helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code.

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FDA Law Blog

JANUARY 18, 2022

a traditional manufacturing site vs. the point of care); The capabilities available at a point-of-care healthcare facility can help mitigate production risks; Entities involved in 3D printing of devices should understand their regulatory responsibilities under the Federal Food, Drug, and Cosmetic Act; and.

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FDA Law Blog

DECEMBER 6, 2023

The Federal Food, Drug, and Cosmetic Act simply did not confer that power upon FDA. The PRIA also omits entire other categories of costs, such compliance with 21 C.F.R. We’ve previously written about this proposed rule (see here , here , and here ) which would transform the diagnostic market in the United States.

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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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Camargo

SEPTEMBER 8, 2021

Of particular concern was a component in the previous iteration that placed product sponsors at a potential compliance risk if the sponsor simply had knowledge of an off-label use of their product. The regulation has been in flux since 2015. Under the final rule, that risk has been mitigated but remains a factor.

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XTalks

JUNE 5, 2023

During a drug shortage, compounders might be allowed to prepare a compounded version of the drug provided they meet specific requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act. As of May 2023, both Ozempic and Wegovy were on the FDA’s Drug Shortages list due to a global shortage of semaglutide.

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Cloudbyz

OCTOBER 19, 2023

Regulatory Compliance: Streamlining processes aids in meeting stringent regulatory requirements and maintaining data integrity. Data Integration: It allows for seamless integration of data from various sources, including electronic health records and wearable devices, ensuring data accuracy and consistency.

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The Pharma Data

APRIL 28, 2022

that are not in compliance with applicable requirements. State and local law enforcement agencies do not independently enforce the Federal Food, Drug and Cosmetic Act and do not, and cannot, take enforcement actions against any violation of FDA’s tobacco authorities, including its regulations, on the FDA’s behalf.

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Advarra

JULY 26, 2022

Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act. So, cannabis derivatives in the form of CBD then became legal in all 50 states.

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FDA Law Blog

JANUARY 1, 2024

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Patcos Cosmetics Pvt. Summaries of the most striking recently released Warning Letters are included below.

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FDA Law Blog

AUGUST 27, 2023

The compliance policies described in the Guidance focus on the requirement that, beginning November 27, 2023, all trading partners generally will be required to use electronic-based approaches to meet the enhanced drug distribution security requirements set forth in in FDCA section 582(g)(1) (Enhanced Drug Distribution Security).

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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

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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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

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. Moreover, Eisai should explain how PTE application for a withdrawn “revoked” of active ingredient BELVIQ® (lorcaserin hydrochloride) is in compliance with requirements of 37 C.F.R.

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Pharma in Brief

JANUARY 10, 2024

Case law updates In 2023, the Patented Medicines (Notice of Compliance) Regulations ( Regulations ) turned 30 years old, inspiring our litigators to consider how the Regulations have evolved since 1993 (see here ). billion over three years to help increase drug access and affordability (see here ).The

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FDA Law Blog

AUGUST 21, 2023

FDA’s jurisdiction over OTC monograph drug labels is clear, but some courts seem to believe that compliance with the label requirements set forth in the relevant monograph is not only not sufficient, but also is discretionary, implicitly chipping away at the authority of the agency.

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FDA Law Blog

OCTOBER 25, 2021

In 1997, the de novo classification process was added to the Federal Food, Drug, and Cosmetic Act (FDCA) by the Food and Drug Administration Modernization Act of 1997. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R.

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FDA Law Blog

AUGUST 17, 2022

While some comments, including those from 41 State Attorneys’ General , raised concerns about the implications of the ambiguity of that preemption proposal and the application to state law, FDA decided against any further clarification.

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