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. In this paper, we will examine what sponsors/investigators need to consider when designing a study with dietary supplements to ensure compliance with the FDA requirements.

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Regulation Research Production Compliance 52

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

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 Doctors Doctor 130

FDA Law Blog

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance. By John W.M. Truly, these are complex considerations.

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Cosmetics Production Compliance Regulation 64

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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Regulation Compliance Contamination Marketing 52

Pharma in Brief

AUGUST 5, 2020

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 ). Background. Minister of Health’s Decision.

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Containment Drugs Regulation Medicine 52

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 130

Cloudbyz

SEPTEMBER 16, 2023

Addressing data privacy and data protection concerns when implementing ChatGPT in clinical trial operations management is crucial to maintain compliance with regulations, safeguard sensitive patient information, and build trust among stakeholders. This may involve conducting regular audits and assessments to maintain compliance.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Compliance 59

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 82

FDA Law Blog

OCTOBER 5, 2022

The proposed rule is intended to align with current nutrition science, the Dietary Guidelines for Americans 2020-2025 and the 2016 nutrition labeling regulation (which also was intended to align with the Dietary Guidelines for Americans). This information is not included in the proposed codified language for the regulation.

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Containment Production Protein Regulation 52

XTalks

MAY 2, 2024

During a midday session, Anal Dave from Dessert Holdings and David Hatch, Vice President of Digital Solutions Marketing at Neogen , showcased their digital transformation strategies in environmental testing, enhancing detection and compliance.

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Compliance Regulation Production Containment 108

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 ). In that case, Manson J. Knowledge of influence.

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Regulation Trials Production Compliance 52

Pharma in Brief

MAY 29, 2023

The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices. Certificate of Supplementary Protection Regulations , SOR/2017-165

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Regulation Sales Clinical Trials Clinical Trials 59

Pharma Marketing Network

JULY 13, 2023

. ● Security: Your website will likely contain sensitive information about your products and customers. Compliance: The pharmaceutical industry is heavily regulated. Make sure the company you choose is familiar with the applicable regulations and can help you ensure your website complies with them.

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Development Regulation Compliance Containment 97

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. As we reported , the export regulations first issued as an interim order in November 2020, in response to the FDA publishing the US Importation Rule in October 2020. 01.014.13).

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Drugs Regulation FDA Approval Manufacturing 52

Pharma in Brief

APRIL 13, 2021

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. Continued authorization for COVID-19 drugs.

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Regulation Drugs Vaccination Vaccine 52

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

FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. By Adrienne R.

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Compliance Marketing Regulation Development 98

FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. Gaulkin & Riëtte van Laack — On May 16, the U.S.

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Containment Contamination Compliance Manufacturing 45

FDA Law Blog

OCTOBER 5, 2023

Earlier this year, DOJ’s CPB issued its own voluntary disclosure policy , which applies more broadly to potential criminal violations “involving the manufacture, distribution, sale, or marketing of products,” as well as “misconduct involving failures to report to, or misrepresentations to” regulators.

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Regulation Compliance Containment Sales 59

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.

Compliance 52

Compliance Cosmetics Regulation Manufacturing 52

CTTI (Clinical Trials Transformation Initiative)

JANUARY 10, 2024

Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders.

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Clinical Trials Clinical Trials Trials Compliance 65

Advarra

OCTOBER 26, 2023

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. The containment must then prevent spills or leaks if the IP is dropped. Size matters.

Production 52

Production Containment Biohazard Biohazard 52

Cloudbyz

FEBRUARY 21, 2023

The TMF contains all essential documents related to the trial, such as study protocols, informed consent forms, investigator brochures, monitoring reports and others. 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 Trials Compliance 88

FDA Law Blog

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

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Compliance Manufacturing Containment Regulation 105

pharmaphorum

JUNE 8, 2022

Conference Chairman: James Drinkwater, Head of Aseptic Processing Special Interest Group PHSS and Head of GMP Compliance, F Ziel GMBH. Join us to discuss and address the Guidance and Regulation including the EU GMP Annex 1, environmental control delving into the contamination control strategy, Pharma moving forward 4.0

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Compliance Contamination Manufacturing Production 52

Pharma in Brief

SEPTEMBER 5, 2023

If classified instead as edible cannabis, Jolts would exceed the THC content per immediate container permitted by the Cannabis Regulations. After initial exchanges, on January 3, 2023, Health Canada issued a Notice of Non-Compliance ( NNC ) with respect to the Jolts line of cannabis products.

Compliance 52

Compliance Production Containment Regulation 52

Cloudbyz

MARCH 30, 2023

Ensure Compliance: Life sciences organizations are subject to various data protection regulations, including GDPR, HIPAA, and CCPA. AI/ML-based redaction solutions can help organizations comply with these regulations by ensuring that sensitive data is not disclosed or transmitted in violation of regulatory requirements.

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Life Science Containment Regulation Clinical Trials 52

Pharma in Brief

SEPTEMBER 8, 2022

On August 17, 2022, the Federal Court dismissed applications for judicial review regarding the product-specificity requirements for addressing patents listed on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Background. Subsection 5(1) is DIN-specific.

Marketing 52

Marketing Drugs Regulation Compliance 52

Pharma in Brief

MARCH 2, 2021

of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ) is not subject to the 45-day limitation period familiar to patentees asserting infringement of listed patents under subsection 6(1). the Plaintiffs ) are involved in litigation under the Regulations against Sandoz Canada Inc. of the Regulations.

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Regulation Compliance Containment Medicine 52

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.

Packaging 98

Packaging Packaging Containment Production 98

XTalks

FEBRUARY 21, 2022

The BioNTainer is housed in shipping containers equipped with state-of-the-art technology for producing the mRNA vaccines from start to finish, except for the final fill-and-finish step that will be performed by local manufacturing partners. Each module contains six standard sized containers, which measure 2.6

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Vaccination Vaccine Production Manufacturing 105

Pharma in Brief

JULY 5, 2021

The Federal Court of Appeal ( FCA ) has confirmed that in an infringement action under the Patented Medicines (Notice of Compliance) Regulations , the “second person” ( i.e. , generic/biosimilar) is not precluded from pleading invalidity allegations in its Statement of Defence beyond those that were raised in its notice of allegation ( NOA ).

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Regulation Compliance Containment Branding 52

pharmaphorum

DECEMBER 13, 2022

Potential regulatory compliance: Regulators recently began recognizing the power of utilizing BYOD devices. Using BYOD means participants no longer need to carry both a personal and a provisioned device, which increases their convenience and comfort and can lead to increased compliance. Potential disadvantages of BYOD.

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Clinical Trials Clinical Trials Compliance Trials 57

Intouch Solutions

APRIL 11, 2024

Instead, it will be a transformational process that affects various functions of the organization, triggering considerations related to data privacy and security, regulatory compliance, and change management. Facilitating cost containment and expediting the content approval process in accordance with regulatory compliance.

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Compliance Marketing Drugs Pharma Companies 52

FDA Law Blog

MAY 3, 2021

While these areas have been the subject of increased enforcement activity because of the national opioid epidemic, DEA registrants should not forget that at the local level compliance with the Controlled Substances Act (“CSA”) and DEA regulatory requirements on recordkeeping, reporting and security remain an Agency priority.

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Compliance Pharmacy Regulation Manufacturing 52

FDA Law Blog

OCTOBER 31, 2021

SB 343 adds additional requirements; it requires that California’s Department of Resources Recycling and Recovery (CalRecycle) update regulations that require disposal facilities to provide information on recycling data. g)(4) of the California Public Resources Code; or. Finally, SB 343 provides that resin identification code numbers (e.g.,

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Packaging Packaging Containment Production 52