Compliance, Containment, Cosmetics and Drugs

Florida approved to import Canadian prescription drugs

Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen.

Drugs

Drugs Regulation FDA Approval Manufacturing

FDA Warns About Compounded Versions of Ozempic and Wegovy

XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). As of May 2023, both Ozempic and Wegovy were on the FDA’s Drug Shortages list due to a global shortage of semaglutide. The approved drugs contain the base form of semaglutide.

FDA Approval

FDA Approval Containment Drugs Pharmacy

FDA Releases Draft CPG on Major Food Allergen Labeling and Cross-Contact

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

Containment Contamination Compliance Manufacturing

Time is (Not) on Your Side: January 1, 2022 Bioengineered Food Disclosure Deadline is Fast Approaching

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.

Compliance

Compliance Cosmetics Regulation Manufacturing

In the News: October 2021 Regulatory and Development Updates

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). The guidance also contains some useful information, despite the limitations described above.

Development

Development Manufacturing Production Packaging

FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

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. 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.

Manufacturing

Manufacturing Production Drugs FDA Compliance

CBD Research: A Dive into the Regulations of Cannabis Research

Advarra

JULY 26, 2022

However, it’s not legal federally and is considered a Schedule I drug by the U.S. Drug Enforcement Administration (DEA), meaning it has no accepted medical use and a high potential for abuse. Cannabis plants and derivatives containing no more than 0.3% Currently, cannabis use is legal across many states in the U.S.,

Regulation

Regulation Research Production Cosmetics

FDA In Brief: Certain Lots of Sportmix Pet Food Recalled for Potentially Fatal Levels of Aflatoxin

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. .” Food and Drug Administration. SOURCE U.S.

Production

Production Cosmetics Compliance Containment

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.

Production

Production Drugs FDA Approval Compliance

FDA Proposes to Harmonize the Quality System Regulation with ISO 13485

FDA Law Blog

MARCH 6, 2022

The gap between QSR requirements and ISO standards has created confusion for companies that focused compliance only on ISO certification. For example, the proposed regulation provides that, for compliance with the ISO section on “Identification,” a device must be labeled with a UDI. See, e.g. , FDA Warning Letter to San Up S.A.

Regulation

Regulation Compliance Manufacturing Packaging

FDA Issues Long-Awaited QMSR Final Rule

FDA Law Blog

FEBRUARY 21, 2024

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. FDA encourages parties to require compliance with such requirements through contractual agreements between manufacturers. Revised § 820.3 FDA further retained some definitions in the QSMR.

Regulation

Regulation Manufacturing Packaging Packaging

Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation

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.

Regulation

Regulation Production Cosmetics Sales

FDA Takes Steps to Limit Lead in Juice to Further Reduce Exposure to Toxic Elements in Foods

The Pharma Data

APRIL 27, 2022

Food and Drug Administration today issued draft action levels for lead in single-strength (ready to drink) apple juice and other single-strength juices and juice blends. The FDA issued a lower draft action level for apple juice because it is the most commonly consumed juice that young children drink. “As

Cosmetics

Cosmetics Production Containment Contamination

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

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.

Regulation

Regulation In-Vitro Manufacturing Licensing

Clinical Research Informer

Florida approved to import Canadian prescription drugs

FDA Warns About Compounded Versions of Ozempic and Wegovy

Trending Sources

FDA Releases Draft CPG on Major Food Allergen Labeling and Cross-Contact

Time is (Not) on Your Side: January 1, 2022 Bioengineered Food Disclosure Deadline is Fast Approaching

In the News: October 2021 Regulatory and Development Updates

FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

CBD Research: A Dive into the Regulations of Cannabis Research

FDA In Brief: Certain Lots of Sportmix Pet Food Recalled for Potentially Fatal Levels of Aflatoxin

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

FDA Proposes to Harmonize the Quality System Regulation with ISO 13485

FDA Issues Long-Awaited QMSR Final Rule

Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation

FDA Takes Steps to Limit Lead in Juice to Further Reduce Exposure to Toxic Elements in Foods

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

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