Putting Patients First Blog

JULY 11, 2024

pharmaceutical manufacturers, academic centers, or other patient organizations). This definition is also applicable across stakeholders and engagement activities (e.g., participation in an interview, focus group). The NHC also acknowledges Ankura Consulting for their partnership and collaboration in the creation of Calculator.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

Viseven

DECEMBER 22, 2022

At the same time, Viseven never misses an opportunity to share our findings and insights with colleagues and clients in our blogs, during live webinar sessions with top industry experts, and, of course, at global events. His article on Omnichannel approaches was published in Pharmaceutical Executive and European Pharmaceutical Manufacturer.

Customer Service 52

Customer Service Pharmaceutical Manufacturing Communication 52

FDA Law Blog: Biosimilars

JUNE 24, 2024

The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceutical manufacturers and other healthcare stakeholders on the latest updates and best practices in dossier development.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

FDA Law Blog: Biosimilars

APRIL 16, 2024

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

Dosage 59

Dosage Drug Pricing Pharmaceutical Manufacturing 59

FDA Law Blog: Biosimilars

MAY 30, 2024

Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. In United Therapeutics Corporation v.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Hospitals 59

Quality Matters

NOVEMBER 5, 2024

Insights from USP’s Medicine Supply Map demonstrate that geographic concentration of pharmaceutical manufacturing anywhere in the world – including within the United States – increases the risk for drug shortages. Promoting geographic diversity of the manufacturing base of U.S.

Pharmaceutical Manufacturing 78

Pharmaceutical Manufacturing Packaging Documentation 78

PharmaState Academy

NOVEMBER 16, 2023

This blog delves into the key insights and perspectives from renowned veterans at The Now & Next Summit in Pharma Marketing 2023. ” The first panel at the Now & Next Summit featured prominent figures from top pharmaceutical companies.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing Communication 52

Express Pharma

MAY 5, 2023

Hence, green chemistry can dramatically minimise the environmental effect of pharma manufacturing by lowering the usage of hazardous chemicals and minimising waste. Improving efficiency and reducing costs: Green chemistry can enhance the effectiveness of pharmaceutical manufacturing processes and decrease waste as well as pollution.

Pharmaceutical Manufacturing 100

Pharmaceutical Manufacturing 100

FDA Law Blog: Biosimilars

AUGUST 14, 2024

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers.

Drug Pricing 59

Drug Pricing Pharmaceutical Manufacturing 59

National Association of Boards of Pharmacy

MARCH 22, 2023

Nonetheless, overall shortages were still high – at roughly the same level as in 2017 after Hurricane Maria damaged pharmaceutical manufacturing facilities in Puerto Rico. This blog was adapted from an article that originally appeared in the January 2023 issue of Innovations. Causes of drug shortages are myriad.

Pharmaceutical Manufacturing 40

Pharmaceutical Manufacturing Hospitals 40

Express Pharma

JUNE 1, 2024

Pharmaceutical manufacturing executives are facing a complex array of cybersecurity challenges, driven primarily by the sector’s increasing digitalisation and the high value of intellectual property. With over 1.9 million attacks in 2022 alone, the urgency for a comprehensive cybersecurity overhaul is evident.

Pharmaceutical Companies 108

Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing Hospitals 108

Pharma and Life Sciences Blog

MAY 22, 2023

Drawing on lessons learned from GEP’s partnerships with a large pharmaceutical manufacturer and other clients, Johnson will outline why it is critical to maintain the right partner mindset, continually track progress, and stay flexible and agile as you work with suppliers.

Pharmaceutical Manufacturing 40

Pharmaceutical Manufacturing 40

Proxsys Rx

OCTOBER 24, 2022

If you aren’t entirely sure whether or not your health system is 340B eligible, Click Here to read our blog post on the topic. The unconscionable 340B program impact of 340B ESP 340B ESP is a website which, it claims, “allows 340B covered entities and pharmaceutical manufacturers to work collaboratively to resolve duplicate discounts.”

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Pharmaceutical Manufacturing 52

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

She also provides consulting services for state licenses, as well as regulatory due diligence concerning licensing requirements, primarily for pharmaceutical manufacturers, wholesale distributers, and pharmacies. Sara is conveniently able to be a client’s one-stop point of contact for licensing needs.

Controlled Substances 45

Controlled Substances Documentation Pharmaceutical Manufacturing Communication 45

Ramblings of a pharmacist

SEPTEMBER 26, 2023

As I’ve discussed before on this blog, counterfeit products DO exist and even have the apparently appropriate T3 documents to validate their legitimacy. First of all - the text of the law passed by Congress and signed into law on 11/27/2013 is available here, on page 562-595.

Communication 105

Communication Pharmaceutical Manufacturing Documentation 105

FDA Law Blog: Biosimilars

JULY 18, 2023

FDA issued 72 CGMP-related warning letters to pharmaceutical manufacturing sites, and over two-thirds of those went to makers of non-application products. Again, the effects of the PHE lingered in this area, as FDA targeted hand sanitizer manufacturers with 31 of those 72 letters.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

FDA Law Blog: Biosimilars

OCTOBER 4, 2023

The court did not make much of Plaintiff’s argument that a manufacturer cannot terminate its participation in Medicare for close to two years, see Motion at 8; Complaint at 27-28, potentially dismissing it as a mere administrative matter. Standing The Defendants questioned, and the court reviewed, Plaintiffs’ standing.

Drug Pricing 59

Drug Pricing Pharmaceutical Manufacturing Immunity Immunization 59

Quality Matters

SEPTEMBER 15, 2023

See also the related Quality Matters blog on industry take-aways from the workshop.] FDA’s Emerging Technology Program “Advanced manufacturing as a concept, as an initiative, has been very important to the agency,” emphasized workshop presenter Adam Fisher, Ph.D., It is not intended as a comprehensive summary or report.

Generic Medicine 52

Generic Medicine Pharmaceutical Manufacturing Communication 52

Quality Matters

SEPTEMBER 15, 2023

PCM not ideal for every drug Continuous manufacturing “may not be fit for every pharmaceutical manufacturing process, but it can bring some advantages in some cases” compared with traditional batch manufacturing, summarized FDA’s Adam Fisher, Ph.D., See related Quality Matters blog on regulatory considerations.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies Dosage 52

Putting Patients First Blog

APRIL 7, 2025

AI in Drug Manufacturing and Quality Control AI technologies are playing an increasingly prominent role in pharmaceutical manufacturing and quality control, offering the potential to enhance process automation, improve efficiency, and ensure consistency in drug production.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

Express Pharma

SEPTEMBER 13, 2024

Therefore, to successfully implement CM in every pharma manufacturing facility, the key focus should be key investments, advancing scientific and technical knowledge, and additional incentives.

Pharmaceutical Manufacturing 105

Pharmaceutical Manufacturing Documentation Vaccines 105

Pharma Marketing Network

JUNE 11, 2020

RJ Lewis (EHS): So today everybody’s a publisher, part of the beauty of the web and even if you don’t have the technical skills for firing up a website or a blog, which is pretty easy. So whether you’re an advertiser or an event coordinator or a supplier in the industry, most of them have pretty active blogs.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing Labelling 52

HealthPartners

MAY 5, 2021

They're signing up for training and asking questions about the journey of prescription drugs from pharmaceutical manufacturers to their employees’ medicine cabinets. The post Pharmacy benefit management demystified: How PBMs influence prescription drug pricing appeared first on Plan Blog. How can this be better managed?

Drug Pricing 40

Drug Pricing Mail-Order Pharmacies Pharmaceutical Manufacturing Pharmaceutical Companies 40

Express Pharma

DECEMBER 19, 2024

Collaboration: A collective responsibility Tackling AMR requires a united effort from governments, pharmaceutical companies, healthcare providers, and consumers. Pharmaceutical manufacturers must ensure that antibiotics are produced sustainably, adhering to stringent environmental standards to minimise contamination.

Pharmaceutical Companies 105

Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing Chemotherapy 105

Express Pharma

JUNE 14, 2024

There have been persistent concerns about AMR being aggravated by effluents from pharmaceutical manufacturing plants. Some studies suggest that the concentrations of antibiotics from this pharmaceutical pollution can be up to 1000 times higher than in hospital effluents or municipal sewage.

Pharmaceutical Companies 110

Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing Packaging 110

Express Pharma

NOVEMBER 15, 2024

Policy push for going green The revised Schedule M, introduced in January 2024, ensures that India’s pharmaceutical manufacturing aligns with international standards for safety and quality. To support MSME pharma companies in meeting these new standards, the government could implement several targeted incentives.

Packaging 102

Packaging Generic Medicine Pharmaceutical Manufacturing Vaccines 102

Putting Patients First Blog

APRIL 3, 2023

Additionally, members, including the NHC, have pledged to 1) Support efforts to advance people’s scientific and health literacy, earn public trust and improve health outcomes and health equity, and 2) Work individually and collectively to correct misinformation and counter disinformation that threatens people’s health and well-being.

Communication 52

Communication Pharmaceutical Manufacturing 52

Express Pharma

JUNE 5, 2024

Also, the proliferation of antimicrobial resistance (AMR), where overuse of antibiotics leads to resistant bacteria, making infections harder to treat Additionally, pharmaceutical manufacturing consumes substantial amounts of solvents, which are typically highly toxic chemicals, as well as heavy metals.

Pharmaceutical Manufacturing 98

Pharmaceutical Manufacturing Packaging Documentation Compounding 98

Express Pharma

DECEMBER 13, 2024

Pharmaceutical manufacturing : Pharmaceutical factories, especially in countries with weaker environmental regulations, can release untreated or inadequately treated waste into nearby water sources, leading to local pollution that harms ecosystems and wildlife.

Compounding 102

Compounding Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 102

Quality Matters

MARCH 13, 2024

This led to new commitments and action to expand Africa’s industrial capacity for pharmaceutical manufacturing. Five products, eight countries Broadly speaking, USP and RHSC seek to promote healthier markets, including through growth in regional manufacturing of health supplies in SSA.

Packaging 69

Packaging Pharmaceutical Manufacturing Hospitals 69

Express Pharma

APRIL 13, 2023

There currently exist bottlenecks in the clinical translation of synthetic lipid-based drug delivery systems owing to pharmaceutical manufacturing, government regulations, and IP. Experimental studies focused on complex multi-functional liposomal formulations are in progress to develop more efficient drug delivery systems.

Vaccines 97

Vaccines Dosage Pharmaceutical Manufacturing Labelling 97

GMPSOP

JULY 14, 2023

In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceutical manufacturing. Equipment cleaning validation protocol was not discussed intensely in this article which was covered elsewhere in this blog.

Documentation 52

Documentation Labelling Pharmaceutical Manufacturing Packaging 52

Express Pharma

MAY 19, 2024

Hyderabad’s strategic focus on biotechnology and pharmaceutical manufacturing has attracted substantial investments, exceeding $700 million in recent years, and this figure may reach a whopping $250 billion by 2030 (8).

Vaccines 52

Vaccines Pharmaceutical Manufacturing 52

Quality Matters

FEBRUARY 19, 2025

India and the United States manufacture most finished medicines for the U.S. market This blog is part of a series on the geographic concentration of pharmaceutical manufacturing. This blog focuses on the manufacturing of finished dose forms. For a discussion on API manufacturing, see here.

Dosage 59

Dosage Pharmaceutical Manufacturing 59