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What’s next for Container Closure Integrity Testing?

Pharmaceutical Technology

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products.

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Here’s Why the USDA Updated its Organic Food Regulations

XTalks

The US Department of Agriculture (USDA) recently updated its organic food regulations to tighten guidelines around organic products. However, products labeled “organic” may contain five percent non-certified organic materials.

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Common medications contain animal byproducts, study finds

Scienmag

No FDA regulations in place to alert patients when medication is derived from animals More physicians and pharmacists are advocating for patients to be made aware of animal byproducts contained in common medications, according to new research in the Journal of Osteopathic Medicine.

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Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The amendments contemplate labelling flexibilities for special containers.

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Will Modernization of Cosmetic Regulation Finally Happen?

FDA Law Blog

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.

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Transforming cold chain infrastructure: ‘Ultra-cold smart container can transport all of the leading vaccine candidates for COVID-19’

BioPharma Reporter

Up to 10% of vaccines can be reportedly lost in transit due to breakage or fluctuations in sub-zero temperatures required for preservation, but a manufacturer of data-driven temperature-controlled smart containers says it can cut that rate to just 0.1%. Markets & Regulations

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MHRA publishes guidance on medicine regulation after Brexit

Pharma Phorum

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. The post MHRA publishes guidance on medicine regulation after Brexit appeared first on.

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IBA – Regulated Information

BioTech 365

October 05, 2020, 17h45 Publication made under article 15 of the law of May 2, 2007 relating to the disclosure of major holdings in issuers whose shares are admitted to trading on a regulated market and containing various provisions (Belgian … Continue reading → GlobeNewswire

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Regulating sanitation services as a public good

The Pharma Data

Services for safely containing, emptying, transporting and treating human waste, and preventing pits and septic tanks from contaminating groundwater and open drains are needed, but without regulation, investments will not prioritize public health outcomes.

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Filing of the 2020 U.S. Form 20-F and French “Document d’Enregistrement Universel” containing the Annual Financial Report

The Pharma Data

Securities and Exchange Commission (SEC) and its “ Document d’Enregistrement Universel ” containing its Annual Financial Report with the French market regulator Autorité des marchés financiers ( AMF ). Sanofi announces today the filing of its Form 20-F with the U.S.

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FDA Publishes Proposal to Redefine the Implied Nutrient Contain Claim “Healthy” Changing Focus to Foods Rather than Nutrients Adding Limits on Added Sugar Content

The FDA Law Blog

The guidance also advised food manufacturers of FDA’s intent to exercise enforcement discretion for foods that are a good source of potassium, and vitamin D, as these two nutrients had been designated nutrients of public health concern in the 2016 final nutrition labeling regulation).

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EU Clinical Trial Regulation: What, When, Who, Why, How?

CATO Research

The long-anticipated European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR), intended to improve and coordinate the submission and review process for clinical trials via a centralized portal, is finally knocking at our doors.

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‘Smart drugs’ may contain unapproved pharmaceuticals, according to a new study

The Pharma Data

Some supplements billed as ‘smart drugs’ may contain unapproved drugs in potentially dangerous combinations and doses, according to a new study. ” These unapproved drugs slip through the regulatory process due to supplements not being strictly regulated by the FDA.

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Is the FDA Doing Enough to Regulate Added Chemicals in Foods?

XTalks

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.

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Clinical Research Regulation in the Netherlands

CATO Research

Before the first human subject receives an investigational medicinal product, the clinical trial has to be approved according to applicable local laws and regulations. In Europe, clinical trials are regulated by the Clinical Trials Directive ( Directive 2001/20/EC ), which is translated into local law by each member state. The post Clinical Research Regulation in the Netherlands appeared first on CATO SMS

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Are you ready for the new European clinical trial regulation?

CATO Research

The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive , the directive that currently describes how clinical trials should be conducted in Europe. The regulation will have a major impact on the conduct of clinical trials.

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PMPRB Update: further-delayed implementation of Patented Medicines Regulations amendments and new Guidelines

Pharma in Brief

Changes to the Patented Medicine Prices Review Board ( PMPRB ) regime, contained in pending amendments to the Patented Medicines Regulations , have been delayed until July 1, 2022. As we reported , the amendments to the Regulations were introduced in August 2019.

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EU regulators begin fast review of dexamethasone for COVID-19

Pharma Phorum

European regulators have begun a speedy review of dexamethasone as a treatment for adults hospitalised with COVID-19, a potentially cheaper option to aid recovery than Gilead’s Veklury. The post EU regulators begin fast review of dexamethasone for COVID-19 appeared first on.

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Proposed amendments to the PM(NOC) Regulations: Patents claiming different salt forms of medicinal ingredients eligible for inclusion on the Patent Register

Pharma in Brief

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.,

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FDA Proposes to Harmonize the Quality System Regulation with ISO 13485

FDA Law Blog

Mullen — On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR). By McKenzie E. Cato & Anne K. Walsh & Allyson B.

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Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. Container closure systems are highly regulated by health agencies. USP and EP Organizations for Container Regulation.

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The structure of DNA is found to be actively involved in genome regulation

Scienmag

The two meters of -stretched- DNA contained in human cells are continuously twisting and untwisting to give access to genetic information: when a gene is expressed to generate a protein, the two strands of DNA are separated to give access to all the machinery necessary for this expression, resulting in an excessive accumulation of coiling […].

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Are you ready for the new European clinical trial regulation?

CATO Research

The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive , the directive that currently describes how clinical trials should be conducted in Europe. The regulation will have a major impact on the conduct of clinical trials. The significant technical complications in the portal and database have delayed the effective date of the new regulation. This resulted in many discrepancies between countries, which will be reduced by the new Regulation.

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Federal Court finds inducement of infringement at summary trial under the PM(NOC) Regulations

Pharma in Brief

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 ).

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PMPRB Update: delayed implementation of Patented Medicines Regulations amendments and new Guidelines

Pharma in Brief

Changes to the Patented Medicine Prices Review Board ( PMPRB ) regime, contained in pending amendments to the Patented Medicines Regulations , have been delayed until January 1, 2022. The amendments contain a number of changes affecting the PMPRB’s review of patented medicine prices.

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Data protection upheld for subsequently approved combination drugs containing new chemical entities: Federal Court finds Minister of Health’s decision to deny generic ANDS filing is reasonable

Pharma in Brief

DESCOVY contains a combination of tenofovir alafenamide ( TAF ) hemifumarate and emtricitabine. GENVOYA is a designated “innovative drug” in respect to TAF pursuant to the data protection provisions of the Food and Drug Regulations , CRC, c 870 ( Data Protection Regulations ).

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FDA Issues Safety Warning Regarding Non-Invasive Prenatal Testing Raising Questions About the Future of FDA Regulation of LDTs

FDA Law Blog

Our readers will recall that this report was issued shortly after FDA’s release of its draft guidance documents seeking to regulate laboratory developed tests. The VALID Act would give FDA authority to regulate laboratory developed tests and fundamentally change the regulatory paradigm for all in vitro diagnostic tests. (As As of this writing, the Senate version of the user fee legislation contains the VALID Act; the House version does not.). By Allyson B.

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Canada amends CSP Regulations, adding UK to list of “timely submission requirement” countries

Pharma in Brief

The change was implemented by an amendment to the CSP Regulations that came into force on January 6, 2021. Impact on “timely submission requirement” CSP eligibility is tied to both a patent and a medicinal ingredient contained in an approved drug.

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Food and Drug Regulations amended: COVID-19 drugs and vaccines transitioned out of interim order framework

Pharma in Brief

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR.

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LA customs agents seize $19m in counterfeit Viagra pills

Outsourcing Pharma

Authorities discovered the fake Pfizer erectile-dysfunction tablets in one of three cargo containers full of fraudulent goods, recently arrived from China. Markets & Regulations

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Health Canada finalizes regulations relating to sale of unapproved drugs for emergency treatment under the Special Access Program

Pharma in Brief

Regulatory amendments to the Food and Drug Regulations ( FDR ) and the Natural Health Products Regulations ( NHPR ) were published in Canada Gazette (Part II) on October 14, 2020. The new regulations also permit “pre-positioning” of a drug in Canada by manufacturers in advance of a request for the drug by a practitioner and authorization by the SAP or the EDR program.

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Sesame Allergies Cause FDA to List Sesame as the 9th Major Allergen

XTalks

The new labeling requirements dictate that the name of the food source of a major allergen must appear either in parentheses following the name of the ingredient, such as “natural flavor (sesame),” or immediately next to the list of ingredients, such as “contains sesame.”.

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Scientists Urge the FDA to Ban Red 3 Color Additive

XTalks

A search of Food Scores , a database maintained by the EWG, generated nearly 3,000 brand-name food products that contain Red 3, including some varieties of Betty Crocker’s Fruit by the Foot, Entenmann’s Little Bites and Hostess’ Ding Dongs.

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Why are Ultra-Processed Foods Linked to Premature Death?

XTalks

However, ultra-processed foods contain more artificial ingredients than those that just have added salt, sugar or oil. They usually have very few whole ingredients and contain flavorings, colorings or other additives.

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Federal Officials Report of HelloFresh E. Coli Outbreak

XTalks

The meal kits containing ground beef for this public health alert were shipped to consumers from July 2-21, 2022,” the FSIS stated in a public health alert. News Food News Food Safety & Regulation News Grocery & Food Service News FSIS Featured Food Safety Foodborne Illness USDA E.

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UK MHRA approves Pfizer-BioNTech’s bivalent Covid-19 booster

Pharmaceutical Technology

Each booster dosage contains 15?g The approval came after the vaccine was found to satisfy the standards of safety, quality and effectiveness of the medicines regulator in the UK. The regulator also recommended people take their booster vaccine during the UK Autumn booster drive.

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Leading commercial packaging companies in contract marketing

Pharmaceutical Technology

The list includes suppliers of a wide range of pharmaceutical packaging, containers and containment solutions, including plastic, glass and other customised packaging solutions, as well as labelling and printing solutions.

Packaging 130
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USDA Confirms Pesticide Residue Levels are Safe in 99 Percent of Produce

XTalks

The US Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) found that most fresh fruits and vegetables contain pesticide residue levels below the tolerances established by the US Environmental Protection Agency (EPA).

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Burger with a Side of Phthalates: New Study Finds Harmful Chemicals in Fast Food Items

XTalks

Additionally, about 89 percent of foods contained some di(2-ethylhexyl) terephthalate (DEHT), a non-phthalate plasticizer. “To The study found higher levels of chemicals in fast-food items containing meat, such as hamburgers and chicken burritos, while cheese pizza had the lowest levels.

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Are Voluntary Food Recalls Truly Voluntary?

XTalks

Last week, Hormel Foods announced a voluntary food recall of 9,353 cases (or about 60,000 jars) of Skippy peanut butter over concerns that a “limited number” could contain stainless steel fragments from an errant piece of manufacturing equipment.

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Pink Sauce: Everything You Need to Know About TikTok’s Controversial Condiment

XTalks

He showed the bottle label that seemed to indicate that it contains 444 servings of the product, at 60 calories per serving of about a tablespoon — a near mathematical impossibility. News Food News Food Safety & Regulation News Featured FDA Food Safety Condiments TikTok Pink Sauce

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Mitigating the risks of cross-contamination during Oral Solid Dose (OSD) manufacturing

Pharmaceutical Technology

As with any pharmaceutical manufacturing, challenges can be many, and processes are highly regulated. This heightens the risk of cross contamination, requiring effective containment solutions, especially when handling highly potent powders.

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Here’s What You Need to Know About Coca-Cola’s Recall

XTalks

Last Friday, The Coca-Cola Company issued a recall of some of its beverages because the affected products may contain pieces of metal bolts, washers or other foreign objects. News Food News Food Safety & Regulation News Featured FDA Food Safety Recall Coca-Cola Minute Maid