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., Proposed PM(NOC) Amendments Restore Balance by Expanding PM(NOC) Regulation Protections.

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Regulation Medicine Generic Drugs Containment 98

BioPharma Reporter

NOVEMBER 24, 2020

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%.

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Containment Vaccination Vaccine Manufacturing 98

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. Some of these chemicals are known endocrine (hormone) disruptors linked to developmental, cognitive and other health problems in babies and adults.

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Regulation Hormones Containment Packaging 94

Fierce Pharma

MAY 17, 2024

A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns. Following a controversy over Covis’ preterm birth drug Makena in the U.S.

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Regulation Drugs Containment Medicine 99

Advarra

JULY 26, 2022

Cannabis plants and derivatives containing no more than 0.3% Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act.

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Pharma in Brief

DECEMBER 23, 2021

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. The amendments to the Regulations contain a number of changes affecting the PMPRB’s review of patented medicine prices. The amendments.

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Regulation Medicine Containment Drugs 72

FDA Law Blog

MARCH 25, 2025

Lenz, Principal Medical Device Regulation Expert Last year, FDA issued a letter to the medical device industry warning medical device firms of concerns related to fraudulent and unreliable laboratory testing data in premarket submissions, which we blogged about here. By Adrienne R.

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Medical Xpress

FEBRUARY 2, 2023

And they share one more thing in common: They likely contain toxic metals. Rice cereal, formula, purees and puffs. They're among the most popular products purchased from the baby food aisle.

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Regulation Containment Research Production 76

World of DTC Marketing

OCTOBER 4, 2021

SUMMARY: The Facebook whistleblower lawsuit can be summed up in one sentence: Facebook prioritizes engagement above all else because it leads to more profits even if that engagement containing inflammatory information. Mt recommendation was no and was based on the amount of health misinformation I found on the site.

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Pharmaceutical Technology

JANUARY 24, 2023

The investigational adeno-associated virus (AAV) gene therapy candidate NGN-401 is claimed to be the first to deliver the full-length human MECP2 gene using the company’s Expression Attenuation via Construct Tuning (EXACT) gene regulation technology.

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Advarra

DECEMBER 17, 2024

As the harmonization effort advances, the focus will likely shift toward refining guidelines and regulations for vulnerable populations, including children, pregnant women, and prisoners. There are many ways in which being a small biotech company, small CRO, or individual site is absolutely wonderful for this industry.

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XTalks

AUGUST 12, 2024

Despite the elimination of many lead-based products in the US, certain goods, especially those imported, may still contain lead. Given that no safe level of lead exposure has been established, the FDA takes a proactive role in monitoring and regulating lead levels in food to protect public health.

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Contamination Compliance Regulation Production 105

STAT News

DECEMBER 23, 2022

While the spending package contains many positive opioid treatment reforms, I am deeply concerned that Congress and others without on-the-ground experience will continue pushing dangerous policies to solve the opioid epidemic in the next Congress. Congress is expected to pass a massive $1.7 to receive high-quality, evidence-based care.

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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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Cosmetics Regulation Production Manufacturing 52

Scienmag

MAY 7, 2021

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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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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Regulation Compliance Medicine Manufacturing 52

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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Packaging Packaging Containment Regulation 98

Pharmaceutical Technology

SEPTEMBER 15, 2022

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. Finding the best commercial packaging suppliers in contract marketing.

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Packaging Packaging Marketing Containment 100

STAT News

MARCH 1, 2023

Between July 2015 and December 2019, Medicare Part D plans covered more than 7,500 prescriptions for so-called TIRF opioid painkillers, which contain fentanyl and are administered through the nose or mouth. The opioids were approved by U.S.

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Containment Regulation Drugs 98

Pharmaceutical Technology

FEBRUARY 3, 2023

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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Contamination Manufacturing Containment Production 130

XTalks

JANUARY 31, 2023

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. When is Food Considered Organic? The USDA has stringent rules for what is considered organic.

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Regulation Production Bacteria Packaging 52

Pharmaceutical Technology

SEPTEMBER 5, 2022

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. Discover the leading direct-to-consumer pharmaceutical marketing companies.

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Marketing Compliance Production Doctors 130

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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Radiology Regulation Manufacturing Production 52

Camargo

NOVEMBER 11, 2020

Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks. The generic drug must also have the same labeling as the RLD (except for differences permitted under the Agency regulations).

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Development Bioequivalency Generic Drugs Production 242

FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. 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.

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Regulation Production Cosmetics Sales 45

pharmaphorum

JANUARY 14, 2022

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.

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Clinical Trials Clinical Trials Trials Clinical Research 126

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. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. By Sophia R.

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Regulation Compliance Contamination Containment 52

Pharmaceutical Technology

FEBRUARY 9, 2023

Container Closure Integrity Testing (CCIT) is used to evaluate the ability of a pharmaceutical’s primary packaging to protect the sterility of its contents. Revised in 2022, EU GMP Annex 1 currently represents the most thorough and up-to-date regulation on the manufacturing of sterile products.

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XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.

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Packaging Packaging Containment Production 98

Camargo

SEPTEMBER 14, 2021

However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during development. The FDA’s Investigational New Drug (IND) application regulations cover all US clinical activities for drugs and biologics.

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Clinical Trials Clinical Trials Medicine Production 144

Outsourcing Pharma

FEBRUARY 6, 2024

Phesiâs artificial intelligence (AI) driven platform, Trial Accelerator, has reached a milestone and now contains global data from more than 100 million patients.

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Trials Containment Regulation Marketing 98

Cloudbyz

FEBRUARY 26, 2023

The TMF contains all essential documents related to the trial, such as study protocols, informed consent forms, investigator brochures, and monitoring reports. Regulatory agencies, such as the FDA or EMA, may inspect the TMF as part of their oversight of clinical trials to ensure compliance with applicable regulations and guidelines.

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Clinical Trials Clinical Trials Compliance Trials 98

XTalks

NOVEMBER 23, 2023

This persistent strain of Salmonella , also known as REPJFX01, not only led to significant illnesses but also prompted a massive recall and stricter regulations on poultry processing. The scandal led to stricter regulations on pesticide use and a push for organic farming methods.

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Pharmaceutical Technology

MAY 24, 2023

Cold chain requirements for CGT are highly stringent and most often at the cryogenic level (below -150 Celsius), which requires the use of specialized containers filled with liquid nitrogen (dewars) and particular shippers requiring specific logistics expertise. This is a primary factor for the staggeringly high unit cost of CGT.

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Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

Scienmag

DECEMBER 10, 2021

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. These chemicals interact with hormone systems, influencing synthesis, regulation, transport, […].

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Hormones Production Containment Regulation 63

XTalks

NOVEMBER 25, 2021

is recalling four lots of its injectable seizure medication levetiracetam over concerns of container closure integrity on vials of the drug product. The integrity of container closures is critical to drug safety. Sagent Pharmaceuticals Inc. This was also associated with a risk of loss of sterility.

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Drugs Packaging Packaging Containment 105

Pharmaceutical Technology

AUGUST 31, 2022

Alongside fitness trackers and smartwatches, there are also medical devices used to monitor a patient’s vitals and some even contain SIM cards to enable two-way communication. Consent on how personal data is used and with whom it is shared is a common concern for consumers and regulators alike.

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Regulation Compliance Insulin Doctors 130