FDA Law Blog

JUNE 17, 2021

Under section 502(ff) of the Food, Drug, and Cosmetic Act, a drug that is manufactured at a facility for which required OMUFA fees have not been paid is deemed misbranded. Given that this is the first year the fees have been assessed, it is not surprising that the list is long.

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The Pharma Data

NOVEMBER 8, 2020

We are very pleased to announce the achievement of two key milestones in our strategy to pursue specific clinical indications that will enable us to market and sell Renuvion ® for target procedures in the cosmetic surgery market,” said Charlie Goodwin, President and Chief Executive Officer.

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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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XTalks

SEPTEMBER 28, 2023

The discrepancy lies in the fact that American food manufacturers can use additives that are banned in Europe due to their associated significant health risks. This meant manufacturers could skip the FDA’s exhaustive safety review process, ensuring their products reached the market faster. BVO tends to accumulate in the human body.

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

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FDA Law Blog

AUGUST 4, 2023

So, through DASCA, Congress targeted those who would circumvent the Controlled Substances Act (“CSA”) by manufacturing anabolic steroids with slightly different chemical structures from those expressly controlled by the CSA but which are intended to cause the same potentially harmful effects. at 50,040 codified at 21 C.F.R.

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FDA Law Blog

JUNE 28, 2023

ASCA was authorized under section 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 2022 Device Submissions with ASCA Testing According to the ASCA 2022 Annual Report , the “FDA received five submissions that contain ASCA testing: four with basic safety and essential performance testing and one with biocompatibility testing.

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Roots Analysis

AUGUST 15, 2023

These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products. Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells.

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XTalks

NOVEMBER 28, 2023

They are banned because they contain non-edible items, posing a risk, particularly to children. Under the provisions of the 1938 Food, Drug, and Cosmetic Act, Kinder Surprise eggs are classified as “adulterated food,” rendering their importation and sale illegal. ” Consequently, this dish is seldom served in the US.

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XTalks

JANUARY 5, 2024

While weight loss service providers such as Weight Watchers and Noom have begun to offer Zepbound and Wegovy through their telehealth services, pharma companies focus on the development and manufacturing side of things and don’t typically involve themselves in home delivery of drugs or connecting patients, providers and pharmacies.

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The Pharma Data

DECEMBER 30, 2020

” Additional Information: The FDA is alerting pet owners and veterinary professionals about certain Sportmix pet food products manufactured by Midwestern Pet Foods, Inc. that may contain potentially fatal levels of aflatoxin. This is in service of FDA’s mission to protect human and animal health.”

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Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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FDA Law Blog

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” By Philip Won & Jeffrey K. Now, with explicit statutory authority, FDA’s push for cybersecurity has a firm legal footing.

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The Pharma Data

NOVEMBER 4, 2020

(TSX: CTX) (OTC US: CRRTF) (“Crescita” or the “Company”), a growth-oriented, innovation-driven Canadian commercial dermatology company with in-house research & development (“R&D”) and manufacturing capabilities, today announced that it has entered into an exclusive agreement with Juyou-Biotechnology Co.

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Advarra

JULY 19, 2022

Also consider quality agreements for key vendors, such as contract development and manufacturing organizations (CDMO) and CROs. Do you search for similar products, and use existing IND criteria requirements against the latest manufacturing guidance docs? Q: What is your advice for approaching the regulatory strategy?

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The Pharma Data

DECEMBER 18, 2020

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. SILVER SPRING, Md. , 18, 2020 /PRNewswire/ — Today, the U.S. SOURCE U.S.

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The Pharma Data

NOVEMBER 26, 2020

We have also launched several new product offerings, most notably a dark chocolate coin (each infused with 20mg CBD) and some skin care/cosmetics selections. The company manufactures and distributes several proprietary retail products and product lines, mainly focused on the Cannabidiol (“CBD”) and Cannabigerol (“CBG”) Edibles market segment.

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The Pharma Data

JANUARY 31, 2021

BIOLASE is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine. BIOLASE’s principal products are revolutionary dental laser systems that perform a broad range of dental procedures, including cosmetic and complex surgical applications. About BIOLASE, Inc.

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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. Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. Under § 820.45, FDA also requires manufacturers to inspect labeling and packaging for accuracy.

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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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Roots Analysis

AUGUST 8, 2023

The hydrophobic portion contains two fatty acid chains with 10-24 carbon atoms, while the hydrophilic part primarily consists of phosphoric acid linked to a water-soluble molecule. Other applications of liposomes include the encapsulation of food and cosmetic materials, along with routine chemical analysis.

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Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The information contained in this statement is as of December 13, 2022. For more information, please visit www.PAXLOVID.com. . IMPORTANT SAFETY INFORMATION

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XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. It contains the antiviral medications nirmatrelvir and ritonavir. every eight weeks for the 90 mg dose, according to the manufacturer. 2022 Revenue: Pfizer reported an annual revenue of $100.33 billion in 2022, a 23.43 billion, a 42.74

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Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . The medications that we obtain in the U.S., and other high-income countries. Far from it.

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XTalks

JULY 26, 2023

Brevel is also actively enhancing its manufacturing capabilities by operating a large-scale 500 liter pilot in Israel; however, the startup is planning to build another, much larger facility by 2025 with an anticipated capacity of 900,000 liters. However, Brevel isn’t the only company using microalgae for food products.

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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. Additionally, for compliance with the ISO section on “Reporting,” a manufacturer must submit medical device reports (MDRs) to FDA pursuant to 21 C.F.R.

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Pfizer

DECEMBER 20, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The information contained in this statement is as of December 20, 2022. For more information, please visit www.PAXLOVID.com. IMPORTANT SAFETY INFORMATION.

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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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FDA Law Blog

JANUARY 18, 2024

Rescheduling Analyses, 2016 DEA noted in 2016 that a drug had a currently accepted medical use for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) under the Federal Food, Drug and Cosmetic Act. 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B). 21 U.S.C. § 802(16)(B).

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Pfizer

NOVEMBER 23, 2022

Europe plays a critical role in the delivery of PAXLOVID to patients across the globe, as the site of four of Pfizer’s key PAXLOVID manufacturing facilities. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

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The Pharma Data

APRIL 27, 2022

In particular, Action Levels for Lead in Juice: Draft Guidance for Industry , provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and of 20 ppb for lead in all other single-strength juice types, including juice blends that contain apple juice. The FDA is accepting comments on the draft guidance.

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Eye on FDA

MARCH 10, 2021

As an agency, FDA issues Warning Letters from multiple sources covering a span of topics and concentrated on various segments of the subject matter jurisdiction of the agency – from food to devices to cosmetics and of course, to the communication by the manufacturers of medicine about their products.

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FDA Law Blog

SEPTEMBER 15, 2022

FDA indicates that this guidance is intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products, which then will allow consumers to compare products. For both draft guidances, it is unclear what induced FDA to publish these draft guidances now.

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FDA Law Blog

NOVEMBER 14, 2022

The facility fee applies to a single manufacturing facility. The guidance explains that a facility counts as a single facility subject to a single facility fee if it is under one management and in one geographic location and address, and is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug product.

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The Pharma Data

DECEMBER 28, 2020

Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com. 5 th ed.

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Pharmacy Checkers

DECEMBER 20, 2019

The agency drafted a new proposed rule to allow importation from Canada of lower-cost drugs and industry guidance for drug manufacturers to import their FDA-approved foreign drug versions, for which they can charge lower prices. Most importantly, Canada and the manufacturers may not cooperate. Well, apparently it can be done.

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