FDA Law Blog

MARCH 21, 2024

Although much remains to be decided and industry is waiting for guidance from FDA related to some of these issues such as serious adverse event reporting, conference discussions all embraced the development of an appropriate internal company infrastructure to handle new requirements as part of a good faith display of compliance. By John W.M.

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XTalks

DECEMBER 7, 2023

These tools are designed to assist stakeholders in achieving compliance before the deadline of January 20, 2026. The Food Traceability Rule, a critical aspect of the FDA Food Safety Modernization Act (FSMA) 204, is designed to expedite the detection and rapid removal of potentially hazardous food from the market. Newly added FAQs.

Compliance 59

Compliance Manufacturing Regulation Production 59

Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

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Marketing Compliance Packaging Packaging 52

World of DTC Marketing

MAY 13, 2021

More specifically, the data revealed 75 percent of physicians do not trust the information provided to them by those marketers. For example, is the message around weight loss for new diabetes drugs really effective when it comes to compliance? Pharma generally needs a small dose of empathy when talking/marketing to physicians.

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Marketing Pharma Companies Branding Doctors 173

Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing.

Packaging 130

Packaging Packaging Marketing Containment 130

Pharma Marketing Network

OCTOBER 14, 2023

In this article, we will explore the challenges of balancing privacy concerns with targeted ads in pharma marketing. Companies must ensure that they are in compliance with these laws, or risk being subject to harsh penalties. In conclusion, balancing privacy concerns with targeted ads in pharma marketing can be a challenging task.

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Marketing Compliance Sales Production 97

Pharma Marketing Network

JULY 12, 2023

In order to succeed in this challenging environment, pharmaceutical companies need to adopt a patient-centric approach to marketing. Patient-centric pharmaceutical marketing is based on the understanding that patients are more than just consumers of drugs. There are a number of ways to create patient-centric pharmaceutical marketing.

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Marketing Compliance Regulation Branding 98

Pharmaceutical Technology

FEBRUARY 23, 2023

The market for UC is filled with various treatment options, and the pipeline is relatively strong. These novel agents are expected to strengthen the market by bringing more innovation to the space. The post New pipeline agents expected to differentiate the UC market appeared first on Pharmaceutical Technology.

Marketing 147

Marketing Trials Compliance Development 147

BioPharma Reporter

MARCH 3, 2022

WuXi STA says its drug product facility in Wuxi City, China has successfully passed its first pre-approval inspection (PAI) and received the GMP compliance certificate from the European Medicines Agency (EMA).

Production 98

Production Compliance Drugs Medicine 98

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.

Marketing 104

Marketing Life Science Compliance Doctors 104

Cloudbyz

MAY 24, 2023

Consumer products companies constantly strive to develop superior products that meet the ever-evolving needs of their consumer base. The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

pharmaphorum

JULY 21, 2022

As a result, some businesses have been forced in the last 18 months to make risk-based decisions based on the resources available to them rather than the quality assurance of a product. Doing so means that businesses can check their compliance before an FDA inspection. Implementing Pharmaceutical Quality systems. She has a Ph.D.

Compliance 98

Compliance Regulation Manufacturing Contamination 98

Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

Marketing 40

Marketing Compliance Packaging Packaging 40

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).

Regulation 52

Regulation Compliance Medicine Manufacturing 52

FDA Law Blog

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

Compliance 52

Compliance Drugs Regulation FDA Approval 52

Advarra

JULY 27, 2022

As a pharmaceutical product makes its way through the lifecycle, there are often Food and Drug Administration (FDA) guidelines organizations should pay particular attention to. Managing regulatory submissions through increased product and process knowledge. Products affecting regulatory pathways are typically already approved.

Production 52

Production FDA Approval Compliance Marketing 52

FDA Law Blog

JUNE 6, 2021

The RAPS Wisconsin Chapter is hosting a webcast on Wednesday, June 23, 2021, discussing device requirements for drug-led combination products. Attendees will gain a broad understanding of integrating device requirements into plans for development, NDA submission, and post market compliance. Hyman, Phelps & McNamara, P.C.’s

Production 52

Production Drugs Compliance Manufacturing 52

Pharmaceutical Technology

SEPTEMBER 5, 2022

Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs. Wholesalers can be either full-line wholesalers, who purchase the complete product line of a company, or specialised companies, which purchase speciality drugs to sell to clinics and hospitals. GDP and GMP advisory.

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Packaging Packaging Compliance Manufacturing 130

The Pharma Data

NOVEMBER 23, 2020

On February 7, 2020 the NYSE American notified the Company that it accepted the Company’s plan to regain compliance before November 25, 2020 , the end of the compliance plan period. This date has now been extended to May 25, 2021. About Synthetic Biologics, Inc. Synthetic Biologics, Inc.

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Compliance Licensing Licensing Clinical Trials 52

Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

Marketing 52

Marketing Regulation Compliance Drugs 52

World of DTC Marketing

DECEMBER 28, 2020

As we look forward to 2021 DTC marketers should be noting the changes in consumer attitudes and the way they request new treatments. DTC marketers need to fall out of love with TV and think about how they translate awareness into brand objectives. Let’s be clear about pharma product websites.

Doctors 296

Doctors Doctor Production Marketing 296

Roots Analysis

APRIL 15, 2024

The production of biologics involves high degree of fragility and sensitivity involving the need for complex manufacturing capabilities, such as fermentation, aseptic fill finish , adequate storage with controlled temperatures and analytical testing to offer quality products.

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Manufacturing Production Contract Manufacturing Contamination 40

Pharmaceutical Technology

JUNE 20, 2023

Lallemand Health Solutions Regulatory and Compliance vice-president Solange Henoud stated: “We are beyond proud! Our product, supported by decades of scientific, marketing and regulatory accomplishments, has achieved the almost impossible nowadays: getting an approval in Brazil! It is the first one this year.

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Compliance Clinical Trials Clinical Trials Production 130

Pharmaceutical Technology

JUNE 21, 2023

Teikoku Pharma, a US subsidiary of Japan-based Teikoku Seiyaku, is supporting the candidate’s route to market with a Phase IIb trial (NCT05412992) being conducted in clinical centres across California and Utah. It cites convenience, ease of administration, and the resulting improved patient compliance as advantages of its transdermal system.

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Compliance Marketing Drugs Production 200

Pharmaceutical Technology

NOVEMBER 1, 2022

FEATURED COMPANIES COMMENDED : • Innovation • Product Launch • Safety VIEW PROFILE COMMENDED : • Business Expansion • Innovation • Investments VIEW PROFILE COMMENDED: • Social VIEW PROFILE. The Excellence Rankings celebrate the greatest achievements and innovations in the industry. What is Social? Ranking Categories.

Compliance 130

Compliance Production Marketing 130

Pharmaceutical Technology

JUNE 29, 2022

For hundreds of years, we have found myriad uses for microbial enzymes in manufacturing – from food, drink, and household products to a range of industrial applications. In 2021, Novo Nordisk Pharmatech, a leading pharmaceutical-grade insulin and Quats product supplier announced plans to enter the enzyme market.

Drugs 295

Drugs Gene Therapy Manufacturing Production 295

Advarra

SEPTEMBER 14, 2023

GxP in Clinical Trials To yield the best possible outcomes for clinical trials, GxP guidelines and compliance regulations assures regulatory agencies the safest and most productive research efforts are being delivered to the market. In more serious instances, sponsors might see their products recalled entirely.

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Clinical Research Compliance Research Regulation 52

Pharmaceutical Technology

SEPTEMBER 13, 2022

This approach will support its manufacturer partners throughout the pharmaceutical development and marketing processes. An international team of scientific, regulatory, and safety and compliance (GxP) specialists, PharmaLex is based in Germany.

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Manufacturing Compliance Marketing Clinical Development 130

Pharmaceutical Technology

SEPTEMBER 5, 2022

The list includes companies that provide a range of services, including but not limited to: · New product/health plan innovation research. Marketing trend analysis. Programmes for treatment adherence and monitoring therapy compliance, and. Programmes for treatment adherence and monitoring therapy compliance, and.

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Branding Production Scientist Compliance 147

Pharma Marketing Network

MAY 3, 2023

The pharmaceutical industry has undergone significant changes in recent years, with digital marketing playing an increasingly important role in the way companies communicate with customers and stakeholders. Another key advantage of digital marketing is the ability to measure and analyze the effectiveness of campaigns in real-time.

Marketing 52

Marketing Compliance Engineer Branding 52

pharmaphorum

JUNE 28, 2016

In today’s competitive, highly regulated environment, product success is dependent upon data and fact-based decision making. More and more, Medical Affairs teams play a pivotal role in education pre- and post-launch, yet the explosion of big data in healthcare is changing how we make value-based decisions that are critical to success.

Compliance 52

Compliance Big Data Regulation Production 52

Advarra

JUNE 26, 2023

Food and Drug Administration (FDA) guidelines is critical to the success, failure, or delay of delivering life-changing therapies to market. A successful FDA inspection can pave the way for continued operations, product approvals, and in some cases, even accelerated go-to-market regulatory pathways.

Compliance 52

Compliance Regulation Marketing Production 52

Pharma Marketing Network

DECEMBER 12, 2023

Upcoming Informa Connect Events: Speaker Programs Summit – February 26-28, 2024 Event Name: Rare Disease Summit – March 19-21, 2024 PAP – Patient Assistance & Access Programs – March 19-21, 2024 Hub and Specialty Pharmacy Models East – March 19-21, 2024 Pharma Forum – March 24-27, 2024 Pharmaceutical Compliance Congress (..)

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Pharma Forum Compliance Life Science Pharmacy 40

Roots Analysis

MARCH 9, 2022

In fact, over 8,000 biological pharmaceutical products are currently under clinical investigation worldwide. . Biopharmaceutical Excipient Manufacturing Market. Biopharmaceutical Excipient Manufacturing Market. Biopharmaceutical Excipient Manufacturing Market. Biopharmaceutical Excipient Manufacturing Market.

Manufacturing 52

Manufacturing Marketing Contract Manufacturing Protein 52

Delveinsight

JANUARY 22, 2021

The launch of a novel drug in the market is not less than a celebration in the pharmaceutical and healthcare market; however, it also brings the real challenge of sustenance in the market. Similar is the picture of the Thrombocytopenia Drugs Market. At present, there stands no treatment option that can cure the disease.

Marketing 65

Marketing Drugs Antibody Compliance 65

pharmaphorum

MAY 18, 2021

A product launch success determines 81% of a drug’s sales performance. Still, research also suggests that many companies are not optimising their strategies for this crucial period: 67% of products fail to meet launch expectations and sales forecasts, and 70% continue to lag behind three years post-launch. ” says Hale.

Production 52

Production Sales Life Science Marketing 52

pharmaphorum

DECEMBER 28, 2022

M&A is an integral part of the lifecycle of pharma companies and a key strategy to future-proof larger players, driving R&D activities and innovation for a competitive product pipeline. In addition to having attractive products, ensuring the supply chain of those products is secure is an increasing concern for companies.

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Compliance Regulation Manufacturing Licensing 117