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

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.

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Compliance Clinical Development Development Clinical Trials 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.

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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).

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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.

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Regulation Compliance Insulin Doctor 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.

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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))).

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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.

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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.

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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.

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Regulation Production Cosmetics Sales 45

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 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

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.

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Clinical Trials Clinical Trials Trials Compliance 59

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

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

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

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.

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Clinical Trials Clinical Trials Clinical Research Trials 98

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 40

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.

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Pharmacy Containment Drugs Compliance 139

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

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

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.

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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

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).

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Production Compliance Manufacturing Regulation 40

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

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.

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Compliance Clinical Trials Clinical Trials Trials 59

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Regulation In-Vitro Manufacturing Licensing 81

FDA Law Blog

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. FDA extended PMTA compliance deadlines for years so it could figure out appropriate application instructions and so that manufacturers could figure out how to comply. FDA failed on each count.

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Production Manufacturing Marketing Regulation 115

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 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package. million).

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Drugs Containment Packaging Packaging 52

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

FDA Law Blog

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3

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Regulation Manufacturing Packaging Packaging 59

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 Manufacturing Compliance 45

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 Regulation Pharmacy Manufacturing 52

XTalks

JULY 5, 2023

True View, the company’s healthcare price transparency tool, contains data on over 500 medical services and more than 4,000 prescriptions. The company’s Healthsparq One platform helps organizations comply with price transparency regulations while driving costs down for both members and insurers.

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Regulation Compliance Containment Marketing 96

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.,

Packaging 52

Packaging Packaging Containment Production 52

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.

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Production Containment Biohazard Biohazard 52