FDA Law Blog

SEPTEMBER 26, 2023

(HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Jeff joins HP&M from Compliance Architects where he served as Vice President of Business Development.

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FDA Law Blog

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. life sciences industry. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C.

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XTalks

JANUARY 9, 2024

Swoop , a leader in healthcare marketing, recently introduced a groundbreaking portfolio of predictive AI targeting for pharmaceutical and life sciences advertisers. This capability will usher in a new era in healthcare marketing, moving beyond traditional methods that rely on past data to a future-focused approach.

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XTalks

JULY 5, 2022

Employee retention and motivation is a challenge that all life science companies face. A corporate compliance training program is a part of many onboarding programs to ensure employees are up to date with the latest rules and regulations they must adhere to while working for the company.

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Pharma in Brief

MAY 4, 2023

The Ontario Superior Court ( ONSC ) has dismissed a claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations ) brought by Apotex Inc. The Court conducted a purposive interpretation of the Regulations and found that Apotex did not meet the statutory requirements for damages.

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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. Sections 4 and 5 work together.

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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 ). Background.

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Pharma in Brief

JULY 25, 2022

The Guide provides a detailed review of the key regimes, including: Data protection market exclusivity; The Patented Medicines (Notice of Compliance) Regulations (PMNOC), linking generic market access to patent rights; Certificate of Supplementary Protection (CSP) exclusivity; Biologics; and.

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Drug Discovery World

FEBRUARY 12, 2024

“In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. The challenge is harnessing the power of AI within a highly regulated industry. The key challenge for all regulators next year is ensuring that they can keep up with the progress of the technology.”

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FDA Law Blog

MARCH 6, 2024

Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY. Prior to HP&M, John served 15 years at the Department of Justice, serving most recently as the Assistant Director of the Consumer Protection Branch, where he led the Corporate Compliance and Policy Unit.

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Drug Channels

MARCH 6, 2023

Experts from across the industry will discuss how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Plus, assess how companies are internally planning for these changes.

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Pharmaceutical Technology

OCTOBER 28, 2022

Designed to explain either the risk management plan (RMP) or clinical trial results (CTR) in a way that a child can understand, lay summaries are now a required document for all clinical trials in the European Union (EU) following changes to EU Clinical Trials Regulations (EU-CTR) regulations earlier this year.

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Pharma in Brief

AUGUST 24, 2022

Importantly, the ONCA decision reaffirms that innovators are not liable beyond damages available under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations ) for the legitimate exercise of their rights under the Patent Act and the Regulations. Background. Eli Lilly Canada Inc.

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Pharma in Brief

MARCH 9, 2021

The Federal Court of Appeal has affirmed one of the last judgments granting a prohibition order under subsection 6(1) of the pre-September 2017 Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations ). ZYTIGA® (abiraterone acetate or AA ) is a drug marketed in Canada by Janssen Inc., Background.

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Pharma in Brief

JANUARY 17, 2024

The Federal Court of Appeal ( FCA ) held that it is abuse of process for a generic or biosimilar manufacturer to split its case across multiple notices of allegation ( NOAs ) under the Patented Medicines (Notice of Compliance) Regulations ( Regulations ). Background Janssen markets INVEGA SUSTENNA® (paliperidone palmitate).

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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 ). collectively, the Plaintiffs ). the PMS Product ). In that case, Manson J.

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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. Eligible drugs must: (i) be approved by Health Canada; and (ii) meet FDA-approval conditions for a drug currently marketed in the US (aside from US labeling). 01.014.8).

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The Pharma Data

NOVEMBER 10, 2020

Crohn’s Disease Therapeutics Market Size $4.7 Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented: “We understand that this will be the first-ever study with ‘take-home’ capsules of any mAb for immunotherapies for human diseases. The CD therapeutic market size will be worth $4.7

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ACRP blog

APRIL 5, 2023

The life sciences sector is increasingly leveraging technology across its operations, and this trend will continue in 2023 with more collaborations and partnerships between pharmaceutical, biotechnology, and medical device companies and information technology vendors, Lyons adds.

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XTalks

JANUARY 29, 2024

Don’t forget to explore the Xtalks Job Search platform to embark on your journey to landing your dream job in the life sciences industry today. Related: Life Science Consulting Jobs: A Unique Career What Does a Healthcare Consultant Do?

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Cloudbyz

APRIL 6, 2023

Cloudbyz offers a range of clinical research management solutions that are integrated with various clinical trials processes, connecting them internally and externally with stakeholders from the life sciences, medical devices, and CRO sectors.

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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.

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pharmaphorum

SEPTEMBER 7, 2020

Wokingham, United Kingdom —4 September 2020 — PRISYM ID, a leading provider of regulated content and label management solutions, has announced the appointment of Robert Bowdish as Director of Clinical Trials Sales for North America. PRISYM ID makes new senior appointment to drive further growth in clinical trials arena. www.prisymid.com.

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pharmaphorum

FEBRUARY 4, 2021

Adams believes this positive start to the year is a sign that life science and medical device companies are looking for expert partners who understand the operational and regulatory challenges facing them and can deliver scalable solutions that meet their unique requirements. “It The challenge now is to lock in these gains.

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Drug Discovery World

JULY 16, 2024

As life sciences companies’ investments in regulatory data capture, enrichment and exchange continue to rise in line with agency mandates, the potential scope for artificial intelligence (AI) and generative AI seems limitless in its promise to transform labour-intensive processes while maintaining high accuracy. But where to start?

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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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pharmaphorum

OCTOBER 27, 2022

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. Therefore, companies are encouraged to establish a methodology for calculating fair market value rates.

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pharmaphorum

JANUARY 20, 2022

Companies seek efficiency and speed to market during the content creation process, review and approval cycles, and thus the collective time for content to be approved for distribution, says Ian Hale, vice president of commercial content at Veeva Systems. Every country has its regulations. Compliant pharma content.

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XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. Merck is also looking to tread into the eye disease market.

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Cloudbyz

MARCH 15, 2023

offers a seamless, secure, and efficient cloud platform for capturing, managing, and analyzing clinical trial data, empowering researchers to deliver life-changing treatments faster and smarter. Compliance & Regulation: Full compliance with FDA 21 CFR Part 11, GDPR, HIPAA, and other global regulatory standards.

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pharmaphorum

OCTOBER 19, 2022

Emma Hyland, VP strategy, commercial content at Veeva Systems, tells us modular content is the most significant wave of innovation hitting the content world in life sciences, and rightly so because HCPs’ needs and expectations have changed. “There isn’t a one-size-fits-all for how the life sciences industry creates content.

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Pharma Business Blog

FEBRUARY 7, 2023

A proposal has been put forward to amend the transitional provisions for certain medical devices and in vitro diagnostic medical devices (amending Regulations (EU) 2017/745 (MDR) 1 and (EU) 2017/746 (IVDR) 2. Taken together, there is the risk of shortages of medical devices on the EU market.

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pharmaphorum

NOVEMBER 30, 2022

Veeva Systems invited pharmaphorum to attend its industry summit in Madrid this week, a huge event that gathered together over 1,000 individuals from life sciences and pharma. The question is, how can the journey there be accelerated, when on the horizon awaits a life sciences future very much immersed in speciality medicine?

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Pharma in Brief

FEBRUARY 28, 2024

Background Janssen markets INVEGA SUSTENNA ® (paliperidone palmitate) for the treatment of schizophrenia and related disorders. PMS ) sought a Notice of Compliance to market a generic version of INVEGA SUSTENNA ® (the PMS Product ). Janssen’s Canadian Patent No. 2,655,335 ( 335 Patent ) teaches a dosing regimen.

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Pharma Business Blog

JULY 27, 2021

With that, as of now Switzerland is considered as a ‘third country’ and Swiss MedTech companies lost their previously barrier-free access to the EU market and vice versa. The Authorised Representative becomes the manufacturer’s representative in the respective market (Switzerland or EU).

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pharmaphorum

JULY 13, 2021

The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations.

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