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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Clinical Research Clinical Trials Clinical Trials Research 80

Camargo

SEPTEMBER 8, 2021

On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. For some time, the FDA has asserted its authority to decide on the classification of a product which met the definition of both a drug and a device.

Development 186

Development Regulation Production Drugs 186

FDA Law Blog

NOVEMBER 16, 2021

Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics. Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters. In the pre-market area, Ms. In addition, Ms.

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40

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 Cosmetics Regulation Manufacturing 52

pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. General Wellness Products. Mobile Medical Applications.

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Development Regulation Production Life Science 100

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). It created the possibility of more easily obtaining information to support new product indications or to help with post-approval study requirements.

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Development Manufacturing Production Packaging 187

pharmaphorum

OCTOBER 27, 2022

The Guidance applies to both product-related and therapeutic-area-related activities. 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.

Life Science 96

Life Science Compliance Regulation Cosmetics 96

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”)

Branding 59

Branding Compliance Regulation Cosmetics 59

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. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

Containment 45

Containment Contamination Compliance Manufacturing 45

FDA Law Blog

JANUARY 18, 2022

Specifically, that it allows for fast production of “patient-matched devices” (i.e., 3D printing has also allowed for production of medical devices such as face shields, face mask holders, nasopharyngeal swabs, and ventilator parts during device shortages caused by the COVID-19 pandemic. products intended for medical purposes).

Manufacturing 98

Manufacturing Regulation Compliance Production 98

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.

Manufacturing 52

Manufacturing Contamination Cosmetics Regulation 52

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

XTalks

JUNE 5, 2023

GLP-1 stimulates insulin production, thus reducing blood glucose levels, and it interacts with the brain to suppress appetite and create a feeling of fullness. Patients and healthcare professionals should understand that certain semaglutide products may not contain the same active ingredient as FDA-approved semaglutide. mg and 2.4

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

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).

Packaging 52

Packaging Packaging Production Manufacturing 52

Advarra

JULY 26, 2022

In order to understand the current status on cannabis and CBD research studies, it’s important to understand where each product stands. Cannabis and cannabis-derived compounds are treated the same as other FDA-regulated products and subject to the same authorities and requirements. The 2018 Farm Bill. Funding Research on Cannabis.

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Regulation Research Production Cosmetics 97

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. Menthol product standard would have significant public health impact. Flavored cigar product standard would reduce youth risk.

Production 52

Production Cosmetics Regulation Manufacturing 52

FDA Law Blog

JANUARY 18, 2022

Specifically, that it allows for fast production of “patient-matched devices” (i.e., 3D printing has also allowed for production of medical devices such as face shields, face mask holders, nasopharyngeal swabs, and ventilator parts during device shortages caused by the COVID-19 pandemic. products intended for medical purposes).

Manufacturing 75

Manufacturing Regulation Compliance Production 75

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. ,

Production 52

Production Cosmetics Compliance Containment 52

The Pharma Data

NOVEMBER 12, 2021

FDA examinations are designed to include the review and evaluation of records, staff training, installation operations, medical device product and testing, and the systems in place to insure product quality. The FDA investigator handed a list of their compliances to the company. Source link: [link].

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Compliance Cosmetics Production Manufacturing 40

XTalks

JANUARY 11, 2024

The US Food and Drug Administration (FDA) has given authorization to Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug and Cosmetic Act (FD&C Act). This means Florida could soon import select prescription drugs from Canada.

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Drugs Cosmetics Medicine FDA Approval 69

The Pharma Data

SEPTEMBER 11, 2020

This is due to these companies violating the Federal Food, Drug and Cosmetic Act which was passed in 1938 to give the FDA authority to oversee the safety of drugs. . We remain committed to using all available tools to stop the illegal sale of opioids online to help protect consumers from these potentially dangerous products.”.

Cosmetics 52

Cosmetics Compliance Pharmacy Doctors 52

FDA Law Blog

JUNE 12, 2023

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. PFI has noted that it is not feasible to develop and label products for an individual state.

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Regulation Production Cosmetics Sales 45

FDA Law Blog

SEPTEMBER 22, 2022

And if the corporation lacks the regulatory and compliance functions necessary to ensure safe products, then it makes sense to punish that corporation. Park, 421 U.S. 658 (1975)). It’s another thing entirely to prosecute individuals who were not involved in the misfeasance and were unaware of the alleged violations.

Cosmetics 59

Cosmetics Production Compliance Drugs 59

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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Regulation Production Drugs Compliance 52

FDA Law Blog

FEBRUARY 21, 2024

The scope of the QMSR is “unchanged” from the QS Regulations, which applies to finished devices and human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated as devices. FDA encourages parties to require compliance with such requirements through contractual agreements between manufacturers. Revised § 820.3

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Regulation Manufacturing Packaging Packaging 59

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].

Cosmetics 52

Cosmetics Production Containment Contamination 52

pharmaphorum

OCTOBER 4, 2022

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). Kyle advises investors, academic medical centres, physician practices, and consultants on a range of business, legal, and regulatory issues affecting the telemedicine industry.

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Development Regulation Cosmetics Life Science 103

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. Our lead product candidates in glaucoma will pave the way for future indications across multiple programs in development.

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Cosmetics Compliance Drugs Development 52

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.

Drugs 52

Drugs Regulation FDA Approval Manufacturing 52

FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The PTO’s ORDER TO SHOW CAUSE points out that: According to the published Federal Register Notice of July 17, 2020, Lilly requested withdrawal “(revocation)” of its BLA for the human biological product LARTRUVO® (olaratumab).

Production 59

Production Drugs FDA Approval Compliance 59

FDA Law Blog

FEBRUARY 12, 2023

Rather than creating its own importation program under Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act), the Food and Drug Administration (FDA) used the statute to create a pathway for States and Indian Tribes (“Sponsors”) to develop such programs (called Section 804 Importation Programs, or SIPs).

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Pharmacy Drugs FDA Approval Cosmetics 97

FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R.

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In-Vitro Regulation Production Compliance 64

FDA Law Blog

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks.

FDA Approval 40

FDA Approval Production Drugs Generic Drugs 40

Pharma in Brief

JANUARY 10, 2024

In 2023, CADTH introduced a new time-limited recommendation pathway to facilitate access to certain therapies (see here ); in tandem, the pCPA published accompanying principles and conditions to inform the negotiation process for eligible drug products (see here ). CDA announced. The Guidance was last updated in 2005. Rare disease strategy.

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Regulation Drugs Production Medicine 52

FDA Law Blog

NOVEMBER 1, 2023

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 ). Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N.

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Regulation In-Vitro Manufacturing Licensing 81

FDA Law Blog

AUGUST 17, 2022

This is important because self-fitting hearing aids require the submission and clearance of a 510(k) while regular OTC hearing aids do not, which provides incentive for manufacturers to self-classify their hearing aid products as regular OTC rather than self-fitting. (FYI,

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Licensing Licensing Regulation Marketing 40