FDA Law Blog: Biosimilars

MAY 22, 2023

The California Department of Food and Agriculture (CDFA) issued regulations implementing Proposition 12 on September 1, 2022, but their implementation was enjoined until July 1, 2023, pending the Supreme Court’s decision. Our focus is on the decision’s practical impact, which could be felt almost immediately.

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Documentation 45

LifeProNow

MARCH 10, 2023

While the agency is in the process of defining its future vision for the Human Foods Program, there is significant need for additional resources to strengthen its foundational food safety and nutrition capacity. Highlights of the agency’s request include: Enhancing Food Safety, Nutrition and Cosmetics $128.2 standard of care.

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Labelling Packaging Controlled Substances 130

FADIC

OCTOBER 20, 2023

The Most Common OTC Resource Navigating Over-the-Counter Choices The Indispensable Guidance of Pharmacists What are Over the Counter (OTC) Medications? The Most Common OTC Resource What Is the Most Commonly Used OTC Medication? What Are the Most Common resource? According to the American Pharmacists Association, of the 3.5

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Health and Personal Care Stores Grocery Stores Labelling Dosage 98

European Pharmaceutical Review

DECEMBER 1, 2023

Additionally, given implementation of the latest EU regulations applicable to medical devices (2017/745 and 2017/746) is “still in its early stages”, there is little information on the impact of these regulations in addressing the falsified medical devices.

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European Pharmaceutical Review

MARCH 28, 2024

The report explained that this is due to the higher expenses and resources requirement to meet complex and “ever-changing” standards. The report also described another obstacle being the difficulty of monitoring and regulating environmental conditions across the entire supply chain. percent between 2024-2030.

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Express Pharma

APRIL 6, 2023

Startups often struggle to understand the regulations and requirements, which can lead to delays and non-compliance. These companies must navigate a variety of regulations and compliance procedures to ensure that their products are safe and effective.

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Labelling Dosage Packaging Documentation 90

Quality Matters

APRIL 17, 2023

USP’s Preferential Access for Regulators (PAR) Program: Supporting the Global Supply of Quality Medicines In the U.S. In low- and middle-income (LMIC) countries, regulators often lack access to quality standards and related resources due to budget constraints or complex procurement procedures.

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Quality Matters

DECEMBER 5, 2022

However, not all countries have the same quality assurance requirements and resources , particularly low- to middle-income countries (LMICs). USP efforts are focused on keeping patients safe by building capacity for quality implementation and regulation across the supply chain. The 1937 incident in the U.S.

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Pharmaceutical Manufacturing 52

pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.

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Documentation 104

epicur

MARCH 12, 2024

For example, Burton (2017) obtained chlorambucil and melphalan from four compounding pharmacies, cyclophosphamide from five pharmacies, and versions of all three drugs from manufacturers following FDA regulations. You’ve probably already heard this with the new USP regulations in place, but it really is the best first step.

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Compounding Chemotherapy Compounding Pharmacies Labelling 52

European Pharmaceutical Review

JUNE 30, 2023

Challenges The first current challenge the author discussed was the supply of materials and conservation of resources for endotoxin testing. Therefore, political climate, geographical location, and regional regulations can limit or cut off supply of endotoxin reagent. One is moving past resource limitations.

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Communication 94

pharmaphorum

DECEMBER 9, 2021

Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends. “As The same principle applies to regulation,” she went on. Life sciences future.

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Vaccines 98

pharmaphorum

SEPTEMBER 8, 2021

.” Fewer staff will therefore be asked to cover more ground with fewer resources, all whilst operating under a pay freeze, they claim. “We will continue to be a world-class regulator that delivers the right outcomes for patients, while we modernise the services we provide to industry, and remain financially stable.”

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FDA Law Blog: Biosimilars

JANUARY 22, 2024

The tools it uses to accomplish that mission include those designed to help regulated entities that want to follow best public health practices, like guidances, public notifications, and requests for information. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. Clinical Trials.

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Compounding Online Pharmacies Communication 59

pharmaphorum

APRIL 14, 2021

A coalition of European academy networks has called upon European Union (EU) leaders to rethink how General Data Protection Regulation (GDPR) rules are applied to health data. Sharing pseudonymised personal health data for public sector research, they went on, is also essential to making most effective use of limited resources. “It

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European Pharmaceutical Review

SEPTEMBER 26, 2023

These database transfer activities must follow industry standards and pharmacovigilance regulation, which has become increasingly stringent over the last decade. However, manual migration does require several operational resources to manually recreate the ICSRs in the target database with new unique case numbers.

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Documentation Data Entry Pharmaceutical Companies Pharmaceutical Companies 101

ALiEM - Pharm Pearls

OCTOBER 26, 2023

Virtual educational programming offers the opportunity to leverage educational resources across space and time, foster collaborations, and improve knowledge, clinical and evidence-based practice globally. Materials Our activity utilized simple, readily available resources. Social cognitive theory of self-regulation.

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Hospitals 156

National Association of Boards of Pharmacy

SEPTEMBER 16, 2022

Our DSCSA State Regulator Pilot project tested a system for sharing this information between regulators and trading partners, including distributors, manufacturers, and others. Stay up to date with these resources: This list of FDA guidance’s. You can learn more about the project and next steps in this report.

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pharmaphorum

NOVEMBER 24, 2021

The Government has committed to relooking at regulation as it determines its own independent trading policy. For any reform to be a success, the MHRA must remain independent, well-resourced and internationally connected. The new Life Sciences Vision details priority areas for enhancing regulation.

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Vaccines Documentation 98

Integra X Files

JULY 17, 2023

This barely scratches the surface of federal resources available and doesn’t even consider the wealth of free information available in state databases. Remember that states license and regulate healthcare providers, so they have more information, but it may be less visible. However, don’t give up.

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Nursing Homes 84

FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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Documentation 64

Pharma Marketing Network

JULY 27, 2023

This could include access to educational resources, evidence-based studies, or training opportunities. These resources can prove indispensable for HCPs and reinforce your commitment to their success and patient care. Ensure that your organization complies with all relevant regulations and guidelines. Transparency is also key.

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European Pharmaceutical Review

AUGUST 29, 2023

Giving Tecentriq subcutaneously now offers patients a faster and more flexible treatment option and can free up resources for healthcare systems, while maintaining its established safety profile,” stated Dr Levi Garraway, PhD, Roche ’s Chief Medical Officer and Head of Global Product Development.

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Immunity Immunization 93

pharmaphorum

NOVEMBER 26, 2020

He told Sky News that additional costs, bureaucracy and delays could follow a no-deal Brexit, or an agreement failing to address the complexity of drug regulation. As companies begin to seek approval from the regulator for new COVID-19 vaccines, it’s critical that we get the roll out right.

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European Pharmaceutical Review

FEBRUARY 8, 2024

Market challenges According to the report, a limiting factor for the market’s growth is regulation, due to its potential role in slowing the adoption of new technologies in the market. Also, a key trend within the market is point-of-care testing, the report stated. Despite the challenges, with an expected to grow at CAGR of 10.3

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Drug Development 90

European Pharmaceutical Review

OCTOBER 9, 2022

EBC-46 contains the protein kinase C (PKC) which regulates gene expression and cell proliferation. The team used lab equipment at the Stanford Neuroscience Microscopy Service, the Stanford Cancer Institute Proteomics/Mass Spectrometry Shared Resource and the Stanford Sherlock cluster for computer modelling.

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Pharma Marketing Network

JULY 19, 2023

This is because the pharmaceutical industry is highly regulated, and businesses need to find creative ways to reach their target audience and educate them about their products and services. Be compliant: Content marketing in the pharmaceutical industry is subject to strict regulations.

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Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

JULY 21, 2022

The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business. 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.

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Pharma Mirror

MAY 7, 2021

Avance Clinical is accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR). This accreditation recognizes that Avance Clinical has the CRO resources and internal processes in place to effectively manage pre-clinical and clinical trials for products involving genetically modified organisms (GMOs).

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Quality Matters

APRIL 18, 2024

USP’s 1,200+ employees and 750+ Expert Volunteers develop these and other quality-focused solutions by working with diverse stakeholders including global manufacturers, regulators, governments, healthcare providers and others. This work helps support biodiversity and minimize environmental impact.

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Pharma Leaders

MARCH 30, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

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Documentation 52

Pharma Leaders

MARCH 21, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

Documentation 52

Documentation 52

Pharma Leaders

MARCH 20, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

Documentation 52

Documentation 52

European Pharmaceutical Review

OCTOBER 1, 2022

In July, The European Commission (EC) drafted a proposal for new regulation for blood, tissue and cell (BTC) donations to aid movement of these products by facilitating cross-border distribution and guaranteeing consistent safety and quality measures.

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Communication 97

Pharmaceutical Technology

FEBRUARY 24, 2023

She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation. European Parliament for Romania member Cristian-Silviu Busoi told the webinar that the legislation is out of date for clinical trials, comparing the EMA’s resources unfavourably with the staffing of China’s NMPA.

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Biosimilars Documentation 64

Express Pharma

JULY 19, 2023

The combined company will focus on advancing Neurogene’s pipeline of differentiated genetic medicines, including NGN-401, a clinical-stage product for Rett syndrome, which uses novel gene regulation technology for a potential best-in-class profile. and trade on the Nasdaq Capital Market under the ticker symbol “NGNE”.

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Pharma Marketing Network

JULY 10, 2023

It can be a complex and challenging process, as pharmaceutical companies must adhere to strict regulations while also developing creative and effective marketing campaigns. This can make it difficult for pharmaceutical companies to develop and implement marketing campaigns that comply with all applicable regulations.

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