Bill of Health

JUNE 26, 2023

Once approved by the FDA, CalRx insulin will be made available at $30 to all Californians who need it. Increased access to drug pricing data can inform innovation policy decisions on exclusivities, competition, and access for the pharmaceutical industry in general. Insulin is the first product the initiative will manufacture.

Pharmaceutical Industry 195

Pharmaceutical Industry Governance FDA Public Health 195

Bill of Health

AUGUST 26, 2022

The selections feature topics ranging from how Wikipedia pages communicate drug efficacy information, to addressing pharmaceutical industry payments to physicians, to the frequency with which the Food and Drug Administration removes hazardous dietary supplements from the market. J Health Polit Policy Law. 2022 Jul 14:10041093.

COVID-19 130

COVID-19 Pharmaceutical Industry FDA 130

Dot Compliance

NOVEMBER 20, 2023

In the pharmaceutical industry, ensuring the safety and quality of drugs is paramount. Food and Drug Administration (FDA) to meet the Current Good Manufacturing Practice (cGMP) standards. The post Navigating FDA Compliance: A Guide to 21 CFR Part 210 and Part 211 appeared first on Dot Compliance.

FDA 52

FDA Compliance Pharmaceutical Industry Regulatory Compliance 52

Dot Compliance

FEBRUARY 5, 2025

These records are essential for ensuring consistency, safety, and compliance in the pharmaceutical industry. Compliance Assessment Check against regulations: Ensure the BMR complies with relevant regulatory requirements, such as FDA, GMP, or ISO standards.

Compliance 59

Compliance Pharmaceutical Industry Regulatory Compliance FDA 59

Kaiser Permanente

JANUARY 21, 2022

In 2016, the 12 largest pharmaceutical companies spent more than $120 billion on marketing , compared to $75 billion on research and development. While some marketing tactics are well known, the following provides more detail on some of the lesser-known tactics that the pharmaceutical industry uses.

Pharmaceutical Industry 98

Pharmaceutical Industry FDA Health Outcomes 98

Healthcare IT Today

FEBRUARY 29, 2024

Unlearn’s technology powers the clinical trials of leading global pharmaceutical companies, helping them to reach full enrollment faster and bring new treatments to patients sooner. Their methods using participants’ digital twins are qualified by the European Medicines Agency and align with current FDA guidance.

Pharmaceutical Industry 128

Pharmaceutical Industry Health Outcomes FDA 128

HIT Consultant

FEBRUARY 1, 2024

Mike Szczesny, Owner & VP of EDCO Awards & Specialties Influencer marketing in the pharmaceutical industry is a complex issue with reasonable arguments on multiple sides. According to the FDA’s website , here are some regulations: Ads must be truthful.

Pharmaceutical Industry 111

Pharmaceutical Industry FDA Public Health Regulatory Compliance 111

HIT Consultant

FEBRUARY 7, 2023

Michael Munsell, Director of Research at Panalgo As the amount of real-world data (RWD) in the pharmaceutical industry continues to grow, so does the usage of machine learning (ML) to analyze that data and gain insights. For the FDA, providing guidelines around RWD usage and beginning to acknowledge RWE steps in the right direction.

FDA 98

FDA Pharmaceutical Industry 98

HIT Consultant

JULY 25, 2022

Lauren Ohlsson, Lead of Industry Solutions, Pharmaceutical and Healthcare, at VDX.tv. Consumers continue to cut ties with traditional TV and cable services, prompting industries like the prescription pharmaceutical industry to evolve their marketing mix to accommodate emerging media. .

Pharmaceutical Industry 98

Pharmaceutical Industry FDA Compliance 98

HIT Consultant

MAY 2, 2022

The FDA is attempting to address this, having issued guidelines related to diversity in clinical trials in November 2020 – perhaps prompted by widespread media coverage of the fact that the black members of the society and other people of color were underrepresented in clinical trials for COVID-19 vaccines.

COVID-19 Vaccine 98

COVID-19 Vaccine COVID-19 Patient Advocacy Pharmaceutical Industry 98

HIT Consultant

MAY 31, 2023

The pharmaceutical industry has experienced a wave of accelerated consolidation since 2010. In 2019, the industry saw a record-breaking 1,276 pharmaceutical M&A’s , representing a total value surpassing $411 billion. In 2017, only four companies were responsible for 50% of generic pharmaceutical drug production.

Pharmaceutical Industry 96

Pharmaceutical Industry Hospitals Telemedicine FDA 96

HIT Consultant

AUGUST 16, 2023

The pharmaceutical industry has long grappled with lengthy timelines and low success rates for new drugs and treatments. But efficient and credible data sharing can spur better processes with the potential to save lives, cut costs, and enable more collaboration across the pharmaceutical industry. years, with only a 7.9%

Pharmaceutical Industry 52

Pharmaceutical Industry Regulatory Compliance FDA Compliance 52

Dot Compliance

SEPTEMBER 30, 2022

The Pharmaceutical Quality Management System (QMS) is a collection of activities and processes that improve the quality of the pharmaceutical product. It focuses on specific persons and processes involved in the production of goods and stops them from straying from quality standards like FDA 21 CFR Part 11, ISO and ICH Q10.

FDA 52

FDA Pharmaceutical Industry Compliance 52

Dot Compliance

JULY 12, 2024

Implementing an electronic quality management system (eQMS) is crucial for organizations in the pharmaceutical industry. By automating documentation and workflows, pharma companies can more easily and quickly meet requirements set by regulatory bodies like the FDA and EMA.

Pharmaceutical Industry 52

Pharmaceutical Industry Regulatory Compliance FDA Compliance 52

Healthcare IT Today

JANUARY 8, 2024

While each company successfully gained FDA approvals, the current market acceptance for prescription digital therapeutics is low and improvements will take years. They will continue to run clinical trials to confirm their claims and value proposition but will not seek FDA approvals. Dave Latshaw, CEO at BioPhy 1.

Pharmaceutical Industry 93

Pharmaceutical Industry Due Diligence Compliance Regulatory Compliance 93

HIT Consultant

NOVEMBER 17, 2021

Recent statements by the FDA and EMA support this emphasis, calling out the need for education and training of all constituents in a clinical trial to reduce unwanted protocol deviations and improve overall quality in clinical trial operations. About Robert Geckeler. Robert Geckeler currently serves as Product Director at ScienceMedia.

COVID-19 97

COVID-19 Pharmaceutical Industry Informed Consent Compliance 97

Dot Compliance

FEBRUARY 1, 2022

The global pharmaceutical industry has seen its share of challenges in recent years, from manufacturing and supply chain bottlenecks to growing demand for faster delivery of drugs to the marketplace. What will the near future bring to the table? Data in the regulatory spotlight. Data is the name of the game in 2022 and beyond.

COVID-19 Vaccine 52

COVID-19 Vaccine FDA Pharmaceutical Industry COVID-19 52

HIT Consultant

MAY 30, 2024

With more than a decade of effort, the pharmaceutical industry has established agreed-upon methods and technologies to exchange transaction information, verify product information, and track products throughout the supply chain, thus improving the security of the U.S. drug supply chain. .”

Pharmaceutical Industry 52

Pharmaceutical Industry Compliance FDA Hospitals 52

HIT Consultant

AUGUST 18, 2021

Food and Drug Administration (FDA), along with greater flexibility around mandates on alternatives to traditional clinical information. These approaches have combined to help accelerate FDA review and study commencement timelines to as low as 30 days. As mentioned, they also began accepting submissions in pieces on a rolling basis.

COVID-19 52

COVID-19 COVID-19 Vaccine Pharmaceutical Industry FDA 52

Dot Compliance

SEPTEMBER 11, 2022

The following is a list of some of the most prevalent rules and regulations that apply to the Pharmaceutical Quality Management System (QMS). Organization for International Standardization (ISO): ISO is a global organization that creates standards for a variety of sectors, including the pharmaceutical industry.

Pharmaceutical Industry 52

Pharmaceutical Industry Compliance FDA Regulatory Compliance 52

SQA

JUNE 3, 2024

Accordingly, the intended users of TR-73-2 are applicants, i.e., pharmaceutical companies, their suppliers, and other interested parties. Since 2011, FDA has made significant strides to modernize and enhance best practices for the efficient initiation, prioritization, development, review, clearance, and issuance of guidance documents.

FDA 40

FDA COVID-19 Licensing Nurses 40

SQA

APRIL 12, 2023

Developed by a multinational team of experts consisting of engineers, toxicologists, hygienists, and analysts from major pharmaceutical companies and suppliers, this Guide aims to consolidate this widely dispersed knowledge base into one document. United States Food and Drug Administration (FDA) Recalls Hospira, Inc. and 225.165).

FDA 40

FDA Compliance Pharmaceutical Industry 40

SQA

APRIL 12, 2023

Developed by a multinational team of experts consisting of engineers, toxicologists, hygienists, and analysts from major pharmaceutical companies and suppliers, this Guide aims to consolidate this widely dispersed knowledge base into one document. United States Food and Drug Administration (FDA) – Recalls Hospira, Inc. and 225.165).

FDA 40

FDA Compliance Pharmaceutical Industry 40

Bill of Health

SEPTEMBER 28, 2023

Senator Sanders’ proposal within PAHPA was ultimately struck from the next iteration of the legislation due to concerns from the pharmaceutical industry and others that such a measure would chill innovation. Federal support by BARDA and the CDC have de-risked the development of medical products for the pharmaceutical industry.

COVID-19 208

COVID-19 COVID-19 Vaccine Pharmaceutical Industry Governance 208

SQA

JULY 8, 2022

88, Microbial Data Deviation Investigations in the Pharmaceutical Industry, January 2022. Food and Drug Administration (FDA) and product manufacturers are aware that it may be present in food and drug products at trace levels, and those very low levels do not pose a safety concern for consumers. PDA Technical Report No.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

SQA

AUGUST 2, 2021

This technical report focuses on the challenges facing the pharmaceutical industry that use complex packaging systems for sterile drugs and biologics (e.g., Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. United States FDA – Guidances for Devices.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Hall Render

FEBRUARY 18, 2022

Meet new FDA chief Dr. Robert Califf: 5 things to know. Outpatient push being felt in architecture industry. Bill on prescription drug pricing inspires support from Maine residents, opposition from pharmaceutical industry. Hospitals urge HHS to fix, not end, direct contracting model.

COVID-19 40

COVID-19 Nursing Homes Nurses COVID-19 Vaccine 40

Bill of Health

SEPTEMBER 12, 2023

By James René Jolin and Susannah Baruch On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. James René Jolin (JRJ): This recent move by the FDA is one without precedent. It was a long time coming.

FDA 189

FDA Pharmaceutical Industry COVID-19 Public Health 189

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

FDA 52

FDA Compliance COVID-19 Public Health 52

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

FDA 40

FDA Compliance COVID-19 Public Health 40

Healthcare IT Today

JANUARY 9, 2023

This could be a breakthrough for the pharmaceutical industry. Lauren Ohlsson, Lead of Industry Solutions – Pharmaceuticals & Healthcare at VDX.tv. In 2023, PLD (Physician Level Data) reporting from digital media partners will become increasingly essential to pharmaceutical organizations.

Pharmaceutical Industry 85

Pharmaceutical Industry Medicare Medicare FDA 85

Bill of Health

DECEMBER 9, 2024

When the pharmaceutical industry proposes developing an ayahuasca pill or a product based on its recipe, Indigenous peoples face challenges in understanding this commercialization. This can criminalize traditional uses, disregarding the cultural and spiritual significance and violating Indigenous rights.

Bioethics 100

Bioethics Pharmaceutical Industry FDA 100

Dot Compliance

DECEMBER 23, 2024

Corrective and Preventive Action (CAPA) plays a key role in maintaining product quality in the pharmaceutical industry, as outlined by the ICH Q10 guidelines. Compliance with Regulatory Requirements: Ensure the CAPA system complies with relevant regulations, including ICH Q10, FDA, and other applicable guidelines.

Pharmaceutical Industry 59

Pharmaceutical Industry Compliance FDA Regulatory Compliance 59

Health Populi

SEPTEMBER 19, 2018

consumers have long-ranked the pharmaceutical industry relatively low, but above car salespeople and the Federal government. In Gallup’s latest poll on Americans’ industry rankings, both healthcare and pharma fell to the lowest net favorability score with the Federal government at rock bottom. For several years, U.S.

Pharmaceutical Industry 54

Pharmaceutical Industry Hospitals Governance FDA 54

Bill of Health

DECEMBER 9, 2024

When the pharmaceutical industry proposes developing an ayahuasca pill or a product based on its recipe, Indigenous peoples face challenges in understanding this commercialization. This can criminalize traditional uses, disregarding the cultural and spiritual significance and violating Indigenous rights.

Bioethics 214

Bioethics Pharmaceutical Industry FDA 214

Hall Render

APRIL 21, 2023

NATIONAL 6 health systems using GPT and AI tools 100,000 nurses left industry during the pandemic, report finds AHA backs bill to delay Medicaid DSH cuts by 2 years AHA launches info hub for healthcare quality leaders AHA opposes MedPAC recommendations to Congress on site-neutral, Part B drug, wage index policies AHA ramps up 340B protection efforts (..)

US Department of Health and Human Services 40

US Department of Health and Human Services COVID-19 Nursing Homes Nurses 40

Kaiser Health News

NOVEMBER 1, 2024

For instance, the FDA could reduce availability of the abortion pill mifepristone or cancel its approval. Kennedy said Trump promised to give him “control” of public health, including naming leaders of the NIH, FDA, and the Centers for Disease Control and Prevention.

ACA 117

ACA FDA Medicaid Medicaid 117