Pharma Tutor

FEBRUARY 2, 2023

FDA Inspections - Overview admin Thu, 02/02/2023 - 13:52 FDA Inspection is a regulatory process conducted by the United States Food and Drug Administration (FDA) to evaluate the compliance of food and drug establishments with FDA regulations and standards.

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Cosmetics Compliance Regulation Manufacturing 52

Pharma in Brief

NOVEMBER 20, 2023

The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations. In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product.

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Production Cosmetics Regulation Branding 52

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.

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Cosmetics Compliance Generic Drugs Regulation 59

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.

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Generic Drugs Manufacturing Drugs Cosmetics 45

Pharma in Brief

JANUARY 7, 2024

Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen. A SIP proposal must, among other requirements, identify a licenced wholesaler in Canada that will purchase the eligible drug directly from its manufacturer. 01.014.13).

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Drugs Regulation FDA Approval Manufacturing 52

FDA Law Blog

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40

XTalks

MARCH 21, 2024

This effort also supports quality manufacturing across the pharmaceutical industry. An additional $8 million is allocated for the Modernization of Cosmetics Regulation Act (MoCRA), which aims to enhance cosmetic product safety. Modernization and Mission Support The FDA food budget proposes $114.8

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Cosmetics Production Regulation Manufacturing 52

FDA Law Blog

APRIL 19, 2021

FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device. The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products.

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Regulation Production Drugs In-Vitro 40

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.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

Manufacturing 98

Manufacturing Regulation Compliance Production 98

Camargo

SEPTEMBER 8, 2021

devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”. PANDAs have historically been overseen by the FDA’s Office of Generic Drugs and thus regulated more like a generic than an NDA. Final Regulation Issued for “Intended Use”.

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Development Regulation Production Drugs 186

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 FDA Compliance 59

FDA Law Blog

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

Production 59

Production Cosmetics Manufacturing Licensing 59

Fossil Remedies

OCTOBER 16, 2022

The next important consideration is a proper distribution channel from the manufacturer to end customers. In a pharma business, you have a distribution network like a pharma manufacturing company, pharma marketing company, C&F agents, wholesalers/distributors/stockiest, retailers, and pharmacies. Manufacturing Drug License.

Licensing 52

Licensing Licensing Pharma Companies Cosmetics 52

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

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.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

Manufacturing 75

Manufacturing Regulation Compliance Production 75

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). FDA Publishes ICH Guidelines on Continuous Manufacturing. FDA Guidance Addresses Real-World Evidence Data Standards.

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Development Manufacturing Production Packaging 187

XTalks

SEPTEMBER 17, 2020

The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. FDA Chief Counsel Stacy Amin said in a statement , “Manufacturing foods in violation of the Produce Safety Rule and Current Good Manufacturing Practice regulations places consumers’ health at risk.

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Production Contamination Cosmetics Bacteria 98

XTalks

APRIL 14, 2023

Last week, the EPA issued a set of proposed rules targeting emission levels at facilities that manufacture ethylene oxide. These regulations are long overdue, by almost a decade. The rules include more stringent regulations that include fenceline monitoring for pollutants from chemical-emitting plants.

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Regulation Scientist Manufacturing Cosmetics 95

XTalks

OCTOBER 8, 2020

Aizon is well positioned to help those manufacturing sectors meet stringent regulatory requirements and extract deeper understanding of complex processes, which ultimately leads to new sources of value,” said John Vitalie, chief executive officer of Aizon, in the press statement from the company. Aizon’s AI Consulting.

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Manufacturing Life Science Cosmetics Regulation 98

FDA Law Blog

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). at 50,040 codified at 21 C.F.R.

Hormones 52

Hormones Manufacturing Regulation Drugs 52

Advarra

SEPTEMBER 8, 2022

One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. In 1997, FDA released regulations providing guidance on the use of electronic systems. Un-specified identified Agency regulations. There are many factors in how Part 11 regulations affect software.

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Compliance Regulation Packaging Packaging 52

FDA Law Blog

MAY 23, 2023

Specifically, field staff are advised to pay close attention to situations where allergen cross-contact may occur because of poor current good manufacturing practices (cGMPs), inadequate preventive controls, or inadequate controls under the juice or seafood HACCP regulations.

Containment 45

Containment Contamination Compliance Manufacturing 45

FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. FDORA added section 515C, “Predetermined Change Control Plans for Devices” to the Federal Food, Drug, and Cosmetic (FD&C) Act. Manufacturers should be able to verify and validate the proposed modifications within their existing quality system.

Manufacturing 98

Manufacturing Marketing Regulation Cosmetics 98

Pharma in Brief

JANUARY 10, 2024

However, many details remain to be addressed in forthcoming regulations. CIPO consulted on proposed features of the regulations in 2023 (see here ), including many factors that would reduce the length of the PTA term. Draft regulations are expected to be released for consultation in 2024. pCPA incorporates.

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Regulation Drugs Production Medicine 52

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. A well-implemented safety vigilance solution ensures that companies stay compliant with these regulations, minimizing the risk of sanctions or penalties.

Cosmetics 52

Cosmetics Compliance Branding Production 52

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. BLA process (CBER).

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Development Production Immune Response Licensing 161

XTalks

NOVEMBER 28, 2023

In the US, the regulation of food products, including the ban on certain items, falls primarily under the jurisdiction of two key agencies: the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA). In response, a modified version called Kinder Joy has been introduced, adhering to FDA regulations.

Sales 52

Sales Regulation Containment Production 52

FDA Law Blog

OCTOBER 25, 2021

Shapiro — After 23 years, de novo classification review finally has an implementing regulation ! The other major review processes have had their regulations in place for many decades. Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Part 807, Subpart E).

Regulation 52

Regulation Manufacturing Cosmetics Compliance 52

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. These proposed regulations do not include a prohibition on individual consumer possession or use.

Production 52

Production Cosmetics Regulation Manufacturing 52

pharmaphorum

OCTOBER 27, 2022

Discussion Forums – If discussion forums are hosted or facilitated by a company, the company should be confident it can moderate the forum such that the content complies with relevant regulations, laws, and codes. Companies should monitor, moderate and, where appropriate, delete inappropriate comments in a timely manner.

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Life Science Compliance Regulation Cosmetics 98

FDA Law Blog

AUGUST 13, 2023

As reported previously , MOCRA includes a requirement for facility registration and listing of cosmetic products. Specifically, with some exceptions, parties that own or operate a facility engaged in the manufacturing or processing of a cosmetic product for distribution in the United States must list their facilities.

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Cosmetics Contract Manufacturing Manufacturing Production 52

FDA Law Blog

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

Containment 52

Containment Radiology Cosmetics Manufacturing 52

FDA Law Blog

MARCH 20, 2022

Baumhardt, Senior Medical Device Regulation Expert & Anne K. The Guidance applies to voluntary recalls of any food, drug intended for human and animal use, any cosmetic, biological, and tobacco product intended for human use, and any item subject to a quarantine regulation under 21 CFR part 1240. By Philip Won & Lisa M.

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Production Regulation Cosmetics Manufacturing 40

XTalks

SEPTEMBER 28, 2023

This is because the US has more lenient food ingredient regulations, potentially exposing consumers to carcinogens and harmful chemicals. 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.

Hormones 52

Hormones Containment Production Cosmetics 52

FDA Law Blog

JUNE 12, 2022

In that case, the DOJ filed a statement of interest , arguing that a violation of the Federal Food, Drug, and Cosmetic Act (FDCA) or implementing regulations may sometimes be “material to the government’s decision whether to pay for the affected product, and thus relevant in an FCA case.”.

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Manufacturing Cosmetics Regulation Production 52

XTalks

JANUARY 19, 2021

This includes some flavored e-cigarettes imported to the US that do not meet Federal Food, Drug and Cosmetic Act (FD&C Act) requirements, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). In the 2020 fiscal year, CBP seized 93,590 units of e-cigarettes that did not meet US federal regulations.

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Production Cosmetics Marketing Branding 98

The Pharma Data

MAY 27, 2022

government partners and domestic and international manufacturers to identify additional formula product that will be available to parents and caregivers in the weeks and months ahead. About 500,000 additional cans of specialized medical formula manufactured by Danone’s Nutricia business will be headed to the U.S. Califf, M.D. “We

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Production Manufacturing Pharmacy Cosmetics 52