Cloudbyz

APRIL 5, 2024

Data Security and Compliance Challenge: Ensuring data security and compliance with regulations like HIPAA and GDPR is critical and challenging, given the sensitive nature of clinical trial data. Implement comprehensive data governance policies, and regularly train staff on data security and privacy regulations.

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Clinical Trials Clinical Trials Regulation Compliance 88

pharmaphorum

DECEMBER 28, 2022

In turn, the acquiring company will help the novel drugs navigate the complexities and costs of regulations and benefit from market access and economies of scale. These teams will include experts in regulatory, GMP compliance and quality systems, often including ex-FDA and MHRA inspectors and industry experts. She joined NSF in 2017.

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Compliance Regulation Manufacturing Licensing 116

Pharma in Brief

NOVEMBER 16, 2020

On October 29, 2020, the Federal Court ordered the Minister of Health to immediately issue a notice of compliance ( NOC ) for a biosimilar drug following a dispute about the effective date of a consent letter under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ).

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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. Drug establishment licensing.

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Regulation Drugs Vaccination Vaccine 52

pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.

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WCG Clinical

APRIL 3, 2023

“Each business day, the new FDAnews will deliver precisely what pharmaceutical and medical device manufacturers have told us they need to know about regulatory compliance and good manufacturing practices,” said Terri Moench, RPh, MS, President, Research Solutions for WCG. Learn more at fdanews.com.

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Compliance Drugs Manufacturing Regulation 52

Pharma Business Blog

MAY 10, 2020

BIOMIN identified this structure as being consistent with the US sanctions regulations. Most probably they did not realize that the Cuban Assets Control Regulations (CACR) applies to US subsidiaries abroad the same way it does to US entities. – Subsidiary of ERBER Group, a “commercially sophisticated” company.

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Pharma in Brief

JANUARY 10, 2024

However, many details remain to be addressed in forthcoming regulations. CIPO consulted on proposed features of the regulations in 2023 (see here ), including many factors that would reduce the length of the PTA term. Draft regulations are expected to be released for consultation in 2024. The Guidance was last updated in 2005.

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Regulation Drugs Production Medicine 52

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks. Co-Authors: Jenny Fielder.

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Development Bioequivalency Generic Drugs Production 242

pharmaphorum

APRIL 28, 2022

billion licensing deal with Biohaven for rights to oral migraine drug rimegepant is approaching a payoff after the European Commission approved the drug. Pfizer’s $1.2 According to GlobalData, Qulipta has the edge when it comes to data on migraine prevention rates and has a broader range of available doses.

Drugs 98

Drugs Marketing Compliance Licensing 98

FDA Law Blog

JUNE 22, 2022

In addition to the significant civil monetary penalties Sovah has agreed to pay, the company is also required to comply with certain extraordinary compliance terms for four years. compliance with all regulations, giving DEA unannounced inspection authority, conducting background checks, etc.), See generally , NPA ¶¶6(a) – (q).

Nurses 52

Nurses Compliance Pharmacy Regulation 52

pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. Improving access to individuals with rare diseases in remote settings.

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Clinical Trials Clinical Trials Trials Packaging 78

The Pharma Data

MAY 14, 2021

Neither ClickBank nor the author are engaged in rendering medical or similar professional services or advice via this website or in the product, and the information provided is not intended to replace medical advice offered by a physician or other licensed healthcare provider. ClickBank is the retailer of products on this site.

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Production Compliance Sales Regulation 52

The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. “These regulations aren’t fit for purpose and don’t protect the public from bad tests,” he said. Image copyright. Getty Images.

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Antibody Regulation Doctors Doctor 52

FDA Law Blog

AUGUST 17, 2022

Where a consumer spends additional money to receive an OTC hearing aid from a licensed professional, the consumer protections required to be provided by the licensed professional apply; otherwise, those consumer protections may not, as state consumer protections typically are required only of licensees.

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Licensing Licensing Regulation Marketing 40

XTalks

AUGUST 25, 2020

The regulator defines these mission-critical inspections as those that would impact US patients’ access to medical products used to treat, diagnose or prevent serious diseases for which there is no other option available. Having a good history of compliance with the FDA could help manufacturers avoid import delays.

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Manufacturing Clinical Trials Clinical Trials Production 89

FDA Law Blog

JUNE 27, 2021

Ensure DEA registrations and state licenses are current and active and copies maintained in an easily accessible file. Mock internal inspections help ensure compliance and instill familiarity and confidence in employees during actual DEA inspections. Maintain an updated copy of all controlled substance policies and procedures.

Drugs 80

Drugs Licensing Licensing Regulation 80

The Pharma Data

JANUARY 18, 2021

In yesterday’s online edition of Forbes magazine, Ahmad Doroudian, CEO of BetterLife, further emphasized the significant barriers that current regulations impose on development of the current generation of psychedelics and LSD based compounds and advantages of non-controlled second generation psychedelics such as TD-0148A.

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Pharma in Brief

JANUARY 10, 2021

s ( Allergan ) silodosin capsules (marketed as RAPAFLO ® ) under an exclusive license in Canada granted by Kissei Pharmaceutical Co., The Court’s decision concerns Canadian Patent No. 2,507,002 ( 002 Patent ), which is listed on the patent register against Allergan Inc.’s Allergan brought an action against Sandoz Canada Inc.

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Manufacturing Regulation Compliance Licensing 52

The Pharma Data

DECEMBER 23, 2020

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect.

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Containment Regulation Compliance Development 52

FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.

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Production Drugs FDA Approval Compliance 59

Drug Discovery World

JANUARY 30, 2024

Intellectual property: High patent royalties and licensing fees for key technologies can inflate treatment costs. Reimbursement models: Current healthcare systems may not have appropriate reimbursement models for the one-time, high-cost nature of CGTs. Fostering open innovation and collaboration could help address this issue.

Gene Therapy 71

Gene Therapy Manufacturing Gene Clinical Trials 71

The Pharma Data

DECEMBER 28, 2020

This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release.

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Containment Drug Delivery Compliance Marketing 52

FDA Law Blog

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Failure to provide notification of a discontinuance or interruption to FDA potentially could, among other things, land a manufacturer on the Drug Shortages: Non-Compliance With Notification Requirement website.

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Manufacturing Production Drugs Marketing 59

FDA Law Blog

MAY 20, 2021

Investigators are known to focus on areas of prior non-compliance for close scrutiny during the current inspection to ensure the registrant has remedied past deficiencies. In our experience, investigators review copies of the registrant’s federal and state licenses. They ask for the results of any state inspections.

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Regulation Compliance Containment Drugs 40

FDA Law Blog

MAY 20, 2021

Investigators are known to focus on areas of prior non-compliance for close scrutiny during the current inspection to ensure the registrant has remedied past deficiencies. In our experience, investigators review copies of the registrant’s federal and state licenses. They ask for the results of any state inspections.

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Regulation Compliance Containment Drugs 40

Clinical Trial Podcast

JULY 18, 2020

Government regulations require that clinical trial data be stored after study close-out. Due to country-specific regulations, a site might be unable to move documents outside their country. Clinical research is a regulated industry. Clinical research is highly regulated. Storage Fees. Administrative overhead.

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Clinical Trials Clinical Trials Trials Clinical Research 98

pharmaphorum

NOVEMBER 30, 2022

As an industry, pharma has specific needs; it is driven by targeted regulations and rules and has not been well served by technology. The whole pharma industry is built on compliance. Coming in April 2023, this will be part of the Engage license. That, he said, is commercial excellence. Veeva is equally ‘super excited’.

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Life Science Pharma Companies Sales Marketing 98

Pharmacy Checkers

FEBRUARY 28, 2020

The report is an audit of companies in the drug supply chain to test compliance with regulations called for by the Drug Supply Chain Security Act of 2013 (DSCSA). The report appears to be a worthwhile effort to test compliance with DSCSA. Yesterday, I was asked by Ed Silverman of STAT NEWS’ Pharmalot. The answer is probably no.

Pharmacy 55

Pharmacy Drugs Sales Compliance 55

Cloudbyz

MARCH 31, 2024

This shift is not merely technological but represents a fundamental rethinking of how clinical trials are conducted, promising to enhance efficiency, compliance, and the overall quality of research outcomes. The disjointed nature of these systems also poses risks to data integrity and auditability, critical factors in regulatory compliance.

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Clinical Trials Clinical Trials Trials Compliance 82

The Pharma Data

DECEMBER 14, 2020

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. Dost Mustaq , BDA International Investor Relations Contact Email: ir@blifepharma.com Phone: 646-679-4321.

Drug Delivery 40

Drug Delivery Containment Manufacturing Drugs 40

The Pharma Data

DECEMBER 20, 2020

This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release.

Drug Delivery 52

Drug Delivery Containment Production Development 52

Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 52

The Pharma Data

MAY 6, 2021

Proposals from the Committee on the Environment, Public Health and Food Safety (ENVI) address how medicines are regulated in the European Union and, to a lesser extent, overseas. Specifically, wholesalers should conduct in-depth audits to verify full compliance with EU GDP requirements. The restriction will apply for two years. .

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Clinical Trials Clinical Trials Medicine Trials 52

FDA Law Blog

AUGUST 3, 2022

Thirty years ago today, FDA announced that it had the authority to regulate you. If anything, the announcement was remarkably inconspicuous: a seemingly throwaway sentence in a draft compliance policy guide for research use only and investigational use only products. By Jeffrey N. Gibbs & Allyson B. 92P-0405 (Aug.

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The Pharma Data

DECEMBER 12, 2020

Morgan Cazenove”) each of which are authorised by the Prudential Regulation Authority and regulated by the Financial Conduct Authority and Prudential Regulation Authority in the UK are each acting as financial adviser exclusively for AstraZeneca and no one else in connection with the matters set out in this announcement.

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