NPR Health - Shots

NOVEMBER 28, 2022

The bottom base of some Green Sprouts products can break off, exposing a solder dot that contains the toxic metal, a federal regulator said. Consumer Product Safety Commission) No injuries have been reported from such incidents. Image credit: U.S.

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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 plants and derivatives containing no more than 0.3% With the exception of one highly purified form of CBD (Epidiolex), no other CBD products are currently FDA approved.

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XTalks

JANUARY 31, 2023

The US Department of Agriculture (USDA) recently updated its organic food regulations to tighten guidelines around organic products. This update comes after a number of allegations claiming farmers have tried to sell non-organic or conventional food products with the lucrative white and green USDA “organic” label.

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Scienmag

DECEMBER 10, 2021

Use of certain personal care products during pregnancy may impact maternal hormone levels, according to a new Rutgers study. Personal care and beauty products contain several ingredients that often include a wide range of endocrine-disrupting chemicals like phthalates, parabens, phenols, parabens and toxic metals.

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Advarra

OCTOBER 26, 2023

Ensuring the safe and secure transport of investigational products (IP) is a core part of biosafety. Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines.

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FDA Law Blog

JULY 7, 2022

Specifically, FDASLA includes the Modernization of Cosmetics Regulation Act of 2022 proposing significant amendments to the FDC Act, intended to modernize safety standards for cosmetics in the United States. The bill includes certain exemptions for small businesses.

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Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).

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Pharma in Brief

APRIL 25, 2021

As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g., different salt forms) of the medicinal ingredient in comparison to the Canadian Reference Product (“ CRP ”).

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FDA Law Blog

FEBRUARY 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Allyson B. Mullen — Sections of the radiological health regulations have been updated with the goal of lessening regulatory burdens. The regulations contain many requirements that are over 30 years old. 360ii, 360kk(a)(1), and 360nn(b))).

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pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on.

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Olympian Clinical Research

FEBRUARY 13, 2024

When it comes to maintaining healthy, vibrant skin, the choice of skincare products plays a pivotal role. At Academic Alliance in Dermatology, we understand the importance of using products that not only care for your skin on the surface but also work effectively at a cellular level.

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The Pharma Data

SEPTEMBER 24, 2020

Some supplements billed as ‘smart drugs’ may contain unapproved drugs in potentially dangerous combinations and doses, according to a new study. The team looked through the National Institute of Health’s Dietary Supplement Label Database and the Natural Medicines Database for products containing unapproved drugs. Conor Kavanagh.

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WCG Clinical

DECEMBER 13, 2023

Dietary Supplements in Research Studies When used as investigational products in a study, dietary supplements may be subject to varying regulations and requirements. Depending on the ingredients of the product and the objectives of the study, the product may be classified as a drug by the FDA and required to comply with 21 CFR 312.

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Camargo

MARCH 25, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications : Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation.

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XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Related: BioNTech to Build First mRNA Vaccine Production Plant in Africa. Photo source: BioNTech.

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XTalks

SEPTEMBER 24, 2020

Despite our best efforts to avoid added chemicals, the food and beverages we consume likely contain one or more of some 10,000 chemicals allowed to be added to foods. Related: FDA Issues First Injunction of its Product Safety Rule.

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Pharmaceutical Technology

NOVEMBER 9, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 Each booster dosage contains 15?g 5 sub-variants.

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XTalks

JANUARY 26, 2023

While the requirement that sesame be listed as an allergen came into effect at the start of 2023, consumers may still find food products for sale that don’t list it on the label since they were produced prior to January 1st. Identifying which foods contain sesame is an important step in food safety and health care as an estimated 0.2

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FDA Law Blog

NOVEMBER 9, 2023

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. Prior notice” informs FDA about the products it can expect to be offered for import into the country. By Sophia R. Gaulkin & Riëtte van Laack — On October 31, 2023, the U.S.

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Camargo

FEBRUARY 16, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Definition of a Rare Disease or Condition.

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Camargo

MAY 19, 2021

The Camargo Blog has published a four-part blog series highlighting those designation programs available specifically for products with rare disease indications. The HUD designation program is designed for medical devices and is similar to the Orphan Drug Designation (ODD) program for drugs and biological products.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. The download contains detailed information on commercial pharmaceutical packaging contractors, and their product and service lines, alongside contact details to aid your hiring decision.

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Pharma in Brief

AUGUST 5, 2020

s ( Gilead ) product DESCOVY as the Canadian Reference Product. DESCOVY contains a combination of tenofovir alafenamide ( TAF ) hemifumarate and emtricitabine. The Minister determined that TAF is a new chemical entity first approved in another Gilead drug product GENVOYA. Background. Minister of Health’s Decision.

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STAT News

JANUARY 9, 2023

Cough medicine tainted with ethylene glycol that killed at least 19 children in Uzbekistan in late December 2022 has once again revealed lax oversight and regulation of pharmaceutical companies based in India. That preventable tragedy, which involves products made by Marion Biotech, based in Noida, India, echoes earlier cases.

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STAT News

OCTOBER 19, 2022

After years of deliberation, the FDA recently announced a new set of rules it proposes to regulate claims on food packaging that a product is “healthy.” ” The most basic rule: the product must actually contain food, not just ingredients.

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Pharmaceutical Technology

MARCH 10, 2023

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies hold permission to market their products directly to consumers. Pharmaceutical companies have also entered the social media marketing domain in compliance with governmental regulations to communicate directly with patients using covert persuasion methods such as collaboration with social media influencers.

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XTalks

JUNE 22, 2023

The Rethink Plastic alliance, in collaboration with a coalition of 81 organizations, is advocating for the integration of effective reuse systems into the European Union’s (EU’s) Packaging and Packaging Waste Regulation. The success of The Better Bagel reflects the growing market demand for low-carb and keto-friendly products.

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The Pharma Data

NOVEMBER 18, 2020

The topic of sanitation regulation is also covered in ‘ Catalysing Citywide Sanitation For All Through Regulating Service Providers ‘ by IWA’s Regulation for Citywide Inclusive Sanitation initiative’s advisory and taskforce members – Yvonne Magawa (ESAWAS), Diego Polania (CRA), and Gustavo Saltiel (World Bank).

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BioSpace

JANUARY 5, 2023

The regulator says drug compounders are selling products that falsely claim to contain the same active ingredient, semaglutide, as the blockbuster diabetes and obesity drugs.

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FDA Law Blog

OCTOBER 5, 2022

It is focused on the nutrients in the food product rather than on it overall nutritional “quality.”. In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition.

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Pharma in Brief

JULY 28, 2020

On July 10, 2020, the Federal Court issued a decision in a judicial review under the Certificate of Supplementary Protection Regulations ( CSP Regulations ). JULUCA ® is a fixed-dose combination ( FDC ) drug product containing the medicinal ingredients dolutegravir and rilpivirine ( JULUCA ).

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Pharma in Brief

JANUARY 26, 2022

The Federal Court has confirmed that issues of infringement, including by inducement, may be decided by summary trial in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). the PMS Product ). Background. In that case, Manson J. Defendant’s inducement to infringe.

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XTalks

JUNE 13, 2024

The passing of the 2018 Farm Bill, which legalized hemp production, boosted the market, allowing companies to explore hemp as a primary ingredient. The US Food and Drug Administration (FDA) plays a crucial role in regulating hemp products, particularly those intended for consumption.

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XTalks

JUNE 21, 2024

The European Union (EU) recently introduced a ban on eight artificial smoke flavorings used in various food products. The European Food Safety Authority (EFSA) found that smoky flavorings can contain harmful chemicals formed during the smoking process. Other companies, like I.T.S

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Pharmaceutical Technology

APRIL 24, 2023

While 80% of the world’s population practices some form of traditional medicine, according to the World Health Organization (WHO), the practice is regularly discredited due to a lack of scientific support and regulation as well as evidence of negative side effects with certain medicines.

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The Pharma Data

MARCH 7, 2022

Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). Today, the U.S. Solomon, D.V.M.,

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