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.

Contamination 105

Contamination Compliance Regulation Production 105

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.

Marketing 130

Marketing Compliance Production Doctors 130

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. Continued harmonization will not only ease the regulatory burden but also facilitate faster study initiation and improve compliance.

Clinical Research 98

Clinical Research Research Trials Clinical Trials 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.

Packaging 100

Packaging Packaging Marketing Containment 100

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.

Clinical Trials 98

Clinical Trials Clinical Trials Compliance Trials 98

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). Manager of Regulatory Compliance. Co-Authors: Jenny Fielder.

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Development Bioequivalency Generic Drugs Production 242

Cloudbyz

AUGUST 19, 2024

Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare. This is where the importance of stringent safety processes, robust systems, and comprehensive regulations comes into play. What is the Medical Device Safety process?

Compliance 52

Compliance Manufacturing Regulation Marketing 52

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry, the existence of non-conformities and deviations is inevitable. Timely intervention is imperative to contain and mitigate potential impact.

Compliance 52

Compliance Clinical Development Development Clinical Trials 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.

Containment 52

Containment Drugs Regulation Medicine 52

FDA Law Blog

MARCH 6, 2022

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). ISO 13485, while largely duplicative to the QSR, is not a perfect fit with other existing FDA regulations.

Regulation 52

Regulation Compliance Manufacturing Packaging 52

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).

Regulation 52

Regulation Compliance Contamination Marketing 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.

Regulation 130

Regulation Compliance Insulin Doctors 130

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.

Regulation 52

Regulation Compliance Contamination Containment 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))).

Radiology 52

Radiology Regulation Manufacturing Production 52

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.

Compliance 98

Compliance Marketing Regulation Development 98

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.

Development 97

Development Regulation Compliance Containment 97

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.

Regulation 45

Regulation Production Sales Cosmetics 45

Pharmaceutical Technology

APRIL 26, 2023

The list also contains companies providing regulatory services, validations, package design verification testing, quality and microbial testing as well as different products, such as sterile barrier pouches and rigid trays for sterile implants, blister packages, strip packages, vials, ampoules, caps, bottles, desiccants and more.

Packaging 130

Packaging Packaging Manufacturing Development 130

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Compliance 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

Vaccine 105

Vaccine Vaccination Production Manufacturing 105

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

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

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.

Regulation 52

Regulation Drugs Vaccine Vaccination 52

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.

Regulation 52

Regulation Trials Production Compliance 52

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.

Containment 52

Containment Production Protein Regulation 52

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.

Regulation 40

Regulation Research Production Compliance 40

pharmaphorum

MAY 5, 2022

Using CDISC standards in a study ensures that any external individual who is not involved in a clinical trial, such as a regulator or another research group, quickly understands all information contained in the clinical trial. And their positive impact is becoming clear to regulatory bodies across the globe.

Clinical Trials 98

Clinical Trials Clinical Trials Clinical Research Trials 98

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.

Compliance 110

Compliance Regulation Production Containment 110

FDA Law Blog

DECEMBER 4, 2023

But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward. Complaint ¶ 60. Complaint ¶ 61. Consent Agreement and Final Judgment ¶ 10.a.-n.

Pharmacy 139

Pharmacy Containment Drugs Compliance 139

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.

Cosmetics 64

Cosmetics Production Compliance Regulation 64

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 Regulation Cosmetics Manufacturing 52

Pharmaceutical Technology

APRIL 18, 2023

The document contains detailed information on the consent and preference management providers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Prioritisation and implementation of effective consent and preference management are important for the transparent and proactive management of data.

Regulation 130

Regulation Production Marketing Containment 130

Camargo

NOVEMBER 15, 2021

In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”. The guidance also contains some useful information, despite the limitations described above. Manager, Regulatory Compliance. Director, CMC Services.

Development 187

Development Manufacturing Production Packaging 187

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

Regulation 59

Regulation Sales Drugs Clinical Trials 59

FDA Law Blog

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

Production 40

Production Compliance Manufacturing Regulation 40

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.

Compliance 105

Compliance Manufacturing Containment Regulation 105

Cloudbyz

JUNE 30, 2024

Regulatory Flexibility: The program contains regulatory flexibility whereby, as much as possible, the FDA approach toward changes in trial design and endpoints happens to meet the challenges arising in accelerated approval but with specific maintenance of rigorous scientific standards.

Compliance 59

Compliance Clinical Trials Clinical Trials Trials 59