European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

The Checkup by Singlecare

APRIL 5, 2024

Health condition Insurance companies are much more likely to cover Ozempic when it’s prescribed for diabetes than for weight loss. That’s because the Food and Drug Administration (FDA) has approved it for Type 2 diabetes , while weight management is technically an off-label treatment.

Insurance 78

Insurance Documentation Insurance Coverage Pharmaceutical Companies 78

pharmaphorum

AUGUST 31, 2021

The industry has looked to regulators for guidance, and the Food and Drug Administration (FDA) has been quick to respond. Within this framework, the FDA seeks to answer outstanding questions on how it will ultimately assess RWD, as well as address any prospective issues, such as cohort bias and data quality.

FDA 89

FDA Insurance Coverage Documentation Pharmaceutical Companies 89

The Checkup by Singlecare

FEBRUARY 7, 2023

Eligible patients will be required to provide documentation of financial and insurance information to show they have no means of obtaining the medication without assistance. Additionally, the drug must be FDA-approved for the condition being treated (i.e., not being used off-label).

Insurance 98

Insurance Insurance Coverage Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

AUGUST 16, 2021

Thankfully, paper-based studies are becoming a thing of the past, but spreadsheets and Word documents are still commonly used to design and build trials. These are now used by several regulatory bodies, including the Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for submission packages.

Documentation 98

Documentation Vaccines Packaging Pharmaceutical Companies 98

pharmaphorum

DECEMBER 28, 2022

So, how do smaller pharmaceutical companies at the cutting edge get ready for their acquisition milestone, so they maximise their value and attractiveness? Any purchasing company would ideally like to integrate their acquisitions into their company seamlessly.

Documentation 119

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 119

Viseven

DECEMBER 4, 2024

Pharmaceutical validation involves evaluating each manufacturing stage to ensure that predefined standards are consistently met. It also requires documenting the entire process, from raw material sourcing to product launch. By optimizing each process, pharmaceutical businesses can minimize waste throughout the production lifecycle.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 52

ISPE

NOVEMBER 1, 2022

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”. Director, Office of Pharmaceutical Quality. Tue, 11/01/2022 - 06:49.

FDA 98

FDA Insurance Chemotherapy Documentation 98

pharmaphorum

SEPTEMBER 28, 2022

“Pharmaceutical companies certainly stand to gain by advancing precision medicine, understanding how an individual’s genetic and biological makeup will react to a medication. Food and Drug Administration (FDA). Minor variations in one’s genetic makeup can impact individual responses to medication.

FDA 98

FDA Documentation Dosage Pharmaceutical Companies 98

Impact Pharmaceutical Services

AUGUST 9, 2022

In 2011, following referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a small development stage pharmaceutical company located in the United Kingdom to assist them with pre-IND activities for a new chemical entity for the treatment of asthma.

Documentation 40

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 40

Viseven

SEPTEMBER 6, 2024

Pharmaceutical companies work with data regularly, and the best way to protect both pharmaceutical industry workers and patients is by achieving full compliance with data integrity requirements and pharmaceutical regulations. This information should cover when the piece of data was created and who did it.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Data Entry Pharmaceutical Companies 52

The Checkup by Singlecare

APRIL 5, 2024

When the Food and Drug Administration (FDA) approved Mounjaro (tirzepatide) in 2022 to treat Type 2 diabetes, some people hailed the GIP and GLP-1 medication as the next great antidiabetic drug. Pharmaceutical companies typically only provide prescription drug samples to healthcare providers, who keep them in the office for patients to use.

Insurance 59

Insurance Compounding Pharmacies Compounding Insurance Coverage 59

ISPE

NOVEMBER 28, 2022

The Advancing Pharmaceutical Quality, Quality Management Maturity Program includes five guidance documents: Corrective Action and Preventive Action (CAPA) : ICH Q10 demonstrates defined requirements for a robust corrective action and preventive action system throughout the product lifecycle. Problem Identification. CAPA Effectiveness.

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

The Checkup by Singlecare

AUGUST 1, 2024

The pharmaceutical supply chain is a complex structure that involves not just pharmacies but manufacturers, wholesalers, pharmacy benefit managers, and insurance companies. While pharmaceutical companies set prices for their drugs, negotiations happen at almost every level, which is why “prices can vary depending on the pharmacy.

Insurance 52

Insurance Insurance Coverage Documentation FDA 52

Pharmaceutical Technology

JANUARY 27, 2023

In 2019, Cablivi became the first FDA-approved , nanobody-based medicine for acquired thrombotic thrombocytopenic purpura (aTTP), an ultra-orphan condition that causes blood clots in small blood vessels around the body. However, it is consistent in regards that it simply seeks provider attestation opposed to actual documentation,” he added.

Documentation 52

Documentation Immunization Pharmaceutical Companies Pharmaceutical Companies 52

Viseven

NOVEMBER 17, 2022

There are also additional responsibilities of these teams, which include : Conducting non-registered clinical trials after the FDA approval of a drug. The role of medical affairs in pharmaceutical companies. New medical affairs employment opportunities are also rising, indicating a revolution in pharmaceutical industries.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Pharmaceutical Technology

SEPTEMBER 23, 2022

generic drugs at both small development companies and multinational pharmaceutical companies. This unique pedigree gives the company a foundational understanding of how to launch products at every stage of development. US-based operations also offer greater access to FDA inspectors which can help speed up approvals.

Packaging 59

Packaging Controlled Substances FDA Documentation 59

Pharmaceutical Technology

OCTOBER 5, 2022

These, along with other similar claims, meant Biogen owed potential damages of $1,036,900,151 to the US and the various States, as per court documents. Ferry describes a popular solution among pharmaceutical companies. The $900 million dollar settlement was previously announced in June but has only been finalized this month.

Documentation 59

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 59

ISPE

JULY 6, 2023

1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Q13 Development Timeline The process of drafting the new guidance document was initiated in earnest in November 2018 when the concept paper 2 and business plan were endorsed.

Documentation 52

Documentation FDA Dosage Pharmaceutical Companies 52

The Checkup by Singlecare

JUNE 25, 2024

Food and Drug Administration (FDA) has approved Wegovy for the treatment of obesity and chronic weight management. Insurance companies have been more likely to embrace the use of GLP-1 agonists for maintaining healthy blood sugar levels to prevent the well-documented, long-term effects of lack of blood sugar control.

Insurance 52

Insurance Insurance Coverage Dosage Labelling 52

Pharma Marketing Network

APRIL 30, 2021

The release in November of FDA’s final guidance on strategies to increase participation of underrepresented populations in trials ( “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry” ) has given added impetus to these efforts.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation FDA 52

European Pharmaceutical Review

SEPTEMBER 22, 2022

The application of Bayesian methodology has been recognised by the US Food and Drug Administration (FDA) as useful in early phase clinical trials involving paediatric populations. Dr Maier has over 25 years of experience in drug development and commercialisation at pharmaceutical companies in Europe, Canada, the United States and Asia.

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 122

ISPE

MARCH 16, 2023

The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination. Automated systems offer a range of options for pharmaceutical companies. Environmental monitoring is another important aspect of Annex 1.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation Compounding 98

pharmaphorum

AUGUST 17, 2021

Sponsors and developers of AIs – including pharmaceutical companies – should set up governance structures to oversee algorithms and AI deployments that are closely linked to the benefit/risk of a medicinal product.

Documentation 116

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 116

pharmaphorum

APRIL 16, 2021

Approval by regulators such as the FDA or EMA, as reported by the regulators themselves. Both the FDA and the EMA rose to the pandemic regulatory challenge very well – addressing the specific COVID treatment and vaccination needs, as well as keeping standard medicines approvals going.

Pharmaceutical Companies 95

Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 95

pharmaphorum

JANUARY 9, 2023

China still hasn’t approved western mRNA vaccines, despite submission, and the US FDA rejects Chinese-only trial data for cancer medicines. For pharma, the impact in critical areas such as the performance of newly marketed innovation has already been documented. Pharma’s starting to wake up to this. Pharma boxed in?

Vaccines 98

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 98

European Pharmaceutical Review

JANUARY 16, 2023

He warned, “Implementation of a CCS will require more than writing documents.”. This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry.

Vaccines 128

Vaccines FDA Research Laboratories Documentation 128

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

FDA 103

FDA Documentation Compounding Pharmaceutical Companies 103

ISPE

MAY 9, 2023

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 5, 2023

For example, one pharmaceutical company that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. 5 In addition, there are human elements to consider.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

Pharmaceutical Technology

FEBRUARY 1, 2023

Pharmaceutical companies have been working on developing vaccines and other prophylactics for respiratory syncytial virus (RSV) since its discovery in 1956. However, RSV has proven to be fully capable of undergoing mutations and viral escape when challenged with pharmaceuticals.

Vaccines 64

Vaccines Documentation Pharmaceutical Companies Pharmaceutical Companies 64

ISPE

JULY 6, 2023

As of 2022, there were 15 drugs (see Table 1) manufactured using CM elements that have received FDA approval, with GSK, Pfizer, and Vertex owning approximately 60% of the market share, followed by Janssen/J&J with about 13%. Table 1: List of FDA-approved commercial products using CM elements.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

The Checkup by Singlecare

MARCH 11, 2025

Food and Drug Administration ( FDA ) to treat Type 2 diabetes mellitus. In addition to prior authorization, Dr. Pasquale says an insurance company may require step therapy before paying for Rybelsus. Step therapy is when treatment failure of other medications are documented to get the medication in question approved, she says.

Insurance 52

Insurance Mail-Order Pharmacies Insurance Coverage Dosage 52