Drug Channels

APRIL 19, 2021

Informa Connect’s Compliance Congress for Specialty Products. June 22-24, 2021 | Virtual Event www.informaconnect.com/specialty-compliance/. Up your compliance game at this important event serving the unique sector of Specialty Products, the 7th annual Virtual Compliance Congress for Specialty Products.

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pharmaphorum

MAY 8, 2024

Could data transparency finally resolve the crisis of drug shortages? This post explores how improved data compliance practices could increase production and end chronic shortages.

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BioTech 365

JULY 21, 2021

FDA (Food and Drug Administration) Regulatory Compliance Course for Pharma and Biotech Products (July 27-28, 2021) – ResearchAndMarkets.com FDA (Food and Drug Administration) Regulatory Compliance Course for Pharma and Biotech Products (July 27-28, 2021) – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “The FDA … (..)

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FDA Law Blog

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. Drug Supply Chain.

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Cloudbyz

APRIL 25, 2023

Pharmacovigilance plays a pivotal role in safeguarding patients from potential adverse effects and ensuring the safety of drugs and medical devices. These reports provide essential information on the safety profile of drugs and medical devices, enabling regulatory authorities to monitor their safety and take appropriate action when necessary.

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Drug Discovery World

FEBRUARY 22, 2024

Join DDW for this free event, Implementing rapid microbial identification in biotherapy manufacturing: Enhancing quality control and regulatory compliance , which is supported by Thermo Fisher Scientific. The post Webinar: Environmental monitoring within biotherapeutic production appeared first on Drug Discovery World (DDW).

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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.

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Drug Discovery World

FEBRUARY 15, 2024

Join DDW for this free event, Implementing rapid microbial identification in biotherapy manufacturing: Enhancing quality control and regulatory compliance , which is supported by Thermo Fisher Scientific. The post Webinar: Understand microbial control in biotherapy production appeared first on Drug Discovery World (DDW).

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Production Genotype Manufacturing Gene Therapy 52

XTalks

DECEMBER 7, 2023

On November 30, the US Food and Drug Administration (FDA) unveiled new resources and Frequently Asked Questions (FAQs) to further educate stakeholders about the Food Traceability Rule under FSMA 204. These tools are designed to assist stakeholders in achieving compliance before the deadline of January 20, 2026. Newly added FAQs.

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FDA Law Blog

DECEMBER 7, 2023

Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week. By Steven J. There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention.

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Pharmaceutical Commerce

JANUARY 31, 2024

Under the DSCSA law, wholesale distributors, re-packagers, dispensers, and other third-party logistics providers must implement interoperable and electronic tracing of prescription products at the package level.

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Cloudbyz

JUNE 10, 2023

21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. Food and Drug Administration (FDA). This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials.

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FDA Law Blog

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization. Valentine, HPM Director.

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FDA Law Blog

DECEMBER 2, 2021

s Anne Walsh will be moderating “Updates in Litigation Risks: Product Liability, Private Litigation, and Consumer Class Actions,” at the upcoming Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference on December 9-10. Hyman, Phelps & McNamara, P.C.’s

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Pharmaceutical Technology

JUNE 14, 2023

A GlobalData report which analyzes trends in new drug approvals [i] shows that small molecule approvals have now been surpassed (in 2022) by biologics. Biologics form 51% of the current global drugs pipeline (highest stage of development as pipeline) according to GlobalData’s Drugs database (as of February 7, 2023).

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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

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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.

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Pharmaceutical Technology

JUNE 19, 2023

Meeting strict client timelines is essential for clinical trials, but complications can arise when dealing with investigational medicinal products (IMPs) across several countries. Staying informed of regulatory changes is crucial for businesses to ensure continued compliance and avoid disruptions in their operations.

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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. Frozen” register. Patent listing eligibility.

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FDA Law Blog

SEPTEMBER 26, 2022

Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 21 C.F.R. §

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Production Compliance Manufacturing Regulation 40

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.

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FDA Law Blog

DECEMBER 15, 2022

By Riëtte van Laack — On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. This concludes FDA’s reevaluation of the regulation of homeopathic drugs which it started in 2015. FDA denied that petition in 2019.

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Drug Discovery World

MAY 30, 2024

This free event will feature insight from Thermo Fisher Scientific’s Jonas Buege, Senior Manager, Product Management, as well as Viki Mahen, Scientist III, Molecular Biology. The post Webinar: Advancing biotherapy manufacturing appeared first on Drug Discovery World (DDW).

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Cloudbyz

MAY 15, 2024

The FDA Center for Veterinary Medicine (CVM)’s draft guidance on pharmaceutical development for veterinary medicines outlines a systematic approach to ensure the quality, safety, and efficacy of veterinary drugs. Efficient document management ensures regulatory compliance and facilitates smooth audits and inspections.

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World of DTC Marketing

JULY 23, 2020

QUICK READ : Prescribers are reviewing some of their favorite prescribed drugs and are open to learning about new drugs in terms of efficacy and patient outcomes but you had better be ready to talk about patients beyond the science. Some may think it’s a bad time to be launching a drug but actually the reverse may be true.

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Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

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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.

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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.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies hold permission to market their products directly to consumers. 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.

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The Pharma Data

MARCH 9, 2021

Eli Lilly and Company (NYSE: LLY) today announced the upcoming retirement of two executive committee members and the naming of their successors in the company’s manufacturing operations and ethics and compliance organizations. Hernandez and Weems will report to David A. .

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Drug Discovery World

MAY 8, 2024

“Our study indicates that cytisinicline might be an option to fill this gap and help adult vapers to stop using e-cigarettes.” The team tested cytisinicline for vaping because the drug binds to nicotine receptors on brain cells. Study drug compliance was high; 72.7% versus 13.2%, respectively (OR, 2.0; [95% CI, 0.82-5.32]).

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pharmaphorum

JULY 28, 2022

The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems. Many of the medicines most badly affected by these shortages are generic drugs to treat common conditions such as diabetes and heart disease.

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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. Drug Channels readers will save 10% off when they use code 23DRCH10 and register prior to March 31, 2023.*

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Pharmaceutical Technology

JANUARY 13, 2023

According to GlobalData’s recently published report, Endometriosis: Global Drug Forecast and Market Analysis , the majority of current medical therapies treat endometriosis by targeting the estrogen production pathways or by modulating the menstrual cycle.

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Pharmaceutical Technology

DECEMBER 15, 2022

Inflation at its current levels poses a major threat to generics production and usage. Since the summer, generics makers have been signalling that additional support for help with rising costs is required to keep generics production viable. Inflation can damage production viability of European drugs.

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Pharma Packaging Solutions

SEPTEMBER 8, 2022

It’s extremely essential to protect pharmaceutical products from damage during shipping and distribution, as faulty medication could have disastrous consequences for consumers. That’s why the drug packaging process is so important, and must be carried out correctly. Primary packaging is the first step in the drug packaging process.

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XTalks

JANUARY 11, 2024

The US Food and Drug Administration (FDA) has given authorization to Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug and Cosmetic Act (FD&C Act). This means Florida could soon import select prescription drugs from Canada.

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