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 skinny label approach has been used extensively by generic manufacturers since it was enacted via the Hatch-Waxman Act in 1984.

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Development Regulation Production Drugs 186

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.” This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. products intended for medical purposes).

Manufacturing 75

Manufacturing Regulation Compliance Production 75

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.

Cosmetics 59

Cosmetics Compliance Generic Drugs Regulation 59

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

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.

Generic Drugs 45

Generic Drugs Manufacturing Drugs Cosmetics 45

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. Novo Nordisk, the pharmaceutical manufacturer of Ozempic and Wegovy, is actively addressing these supply challenges.

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FDA Approval Containment Drugs Pharmacy 98

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.

Life Science 98

Life Science Medicine Regulation Compliance 98

FDA Law Blog

MARCH 6, 2022

It is very common for a medical device manufacturing facility both to be certified as compliant with ISO 13485 and to have quality system procedures designed to comply with the FDA’s QSR. The gap between QSR requirements and ISO standards has created confusion for companies that focused compliance only on ISO certification.

Regulation 52

Regulation Compliance Manufacturing Packaging 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.

In-Vitro 81

In-Vitro Regulation Manufacturing Licensing 81

FDA Law Blog

FEBRUARY 21, 2024

It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. It also specifies that manufacturers document the Unique Device Identifier (UDI) for each medical device or batch of medical devices in accordance with Part 830, Unique Device Identification.

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Regulation Manufacturing Packaging Packaging 59

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.

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40

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.

Containment 45

Containment Contamination Manufacturing Compliance 45

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. Biologics, controlled substances, and certain other drugs are not eligible for importation.

Drugs 52

Drugs Regulation FDA Approval Manufacturing 52

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

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. By Riëtte van Laack — FDA regulates pet food similar to other animal foods.

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Regulation Production Cosmetics Sales 45

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. In the PMA context, the statute permits FDA to withhold approval if manufacturing facilities do not conform to QSR requirements. Part 807, Subpart E). 515(d)(2)(C).

Regulation 52

Regulation Manufacturing Cosmetics Compliance 52

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. This timing undermines the Agency’s rationale that three years is enough time to come into compliance.

In-Vitro 64

In-Vitro Regulation Production Compliance 64

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,

Licensing 40

Licensing Licensing Regulation Marketing 40

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.,

Manufacturing 52

Manufacturing Contamination Cosmetics Regulation 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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Manufacturing Production Drugs Contract Manufacturing 59

The Pharma Data

NOVEMBER 12, 2021

In response to the recall, the FDA lately conducted an examination of a Philips Respironics’ manufacturing installation to determine what may have caused or contributed to the froth issues and assess adherence to the agency’s conditions for quality manufacturing. The FDA investigator handed a list of their compliances to the company.

Cosmetics 40

Cosmetics Compliance Production Manufacturing 40

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

Pharma in Brief

JANUARY 10, 2024

The pCPA negotiates with manufacturers on behalf of Canada’s provincial, territorial, and federal governments. 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 ).

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Regulation Drugs Production Medicine 52

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. Just like it was over a decade ago in Pliva v.

FDA Approval 40

FDA Approval Production Drugs Generic Drugs 40

FDA Law Blog

MARCH 9, 2025

The American Conference Institutes 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025, at the New York City Bar Association, New York, NY. FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount.

Cosmetics 59

Cosmetics Compliance Contamination Regulation 59

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.

Drugs 69

Drugs Cosmetics Medicine FDA Approval 69

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. that are not in compliance with applicable requirements. Source link: [link].

Production 52

Production Cosmetics Regulation Manufacturing 52

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. , This is an ongoing investigation.

Production 52

Production Cosmetics Compliance Containment 52

FDA Law Blog

JANUARY 14, 2025

By Ritte van Laack A little over two years ago, the Modernization of Cosmetic Regulation Act (MoCRA) was (at long last) enacted. Excitement that after about a decade the FDC Act finally was amended giving cosmetics more legitimacy; anxiety because MoCRA seemed a substantial change for many involved in the business of cosmetics.

Cosmetics 59

Cosmetics Manufacturing Regulation Containment 59

FDA Law Blog

OCTOBER 14, 2024

HTC/Ps in this last category are regulated as drugs or medical devices under the FDCA, or biological products under section 351 of the PHSA, which typically require premarket approval and compliance with the full panoply of FDA regulation. California Stem Cell Treatment Center, Inc.,

Regulation 59

Regulation Drugs Containment Licensing 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).

Pharmacy 97

Pharmacy Drugs FDA Approval Cosmetics 97

FDA Law Blog

JANUARY 9, 2024

Kirschenbaum — The law permitting the importation of cheaper prescription drugs from Canada—Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act)—has been on the books for decades. By Faraz Siddiqui & Alan M. See 21 C.F.R. 251.5; § 251.6(c). Proposed relabeling and proposed NDC numbers for the drugs to be imported.

FDA Approval 59

FDA Approval Drugs Manufacturing Compliance 59