The FDA Law Blog

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.

Documentation 45

Documentation 45

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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The Checkup by Singlecare

FEBRUARY 9, 2023

As a pharmacist, you are likely well aware of what the Drug Enforcement Agency (DEA) calls your “corresponding responsibility” in section Title 21 of the Code of Federal Regulations. Note that some states have different laws or regulations that are more stringent than the federal level; in this case, the stricter law always takes precedence.

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Controlled Substances Insurance Coverage Insurance Labelling 96

ISPE

MAY 1, 2023

On a high level, the validation master plan mentioned that the CSV approach had to be compliant with several regulations and standards and also here is was not clear whether this was consistent with the underlying controls. Better Acceptance Room for interpretation means room for discussion between the different roles or resources.

Documentation 98

Documentation 98

The FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. There are many resources that provide information and guidance for each of these required elements.

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Documentation FDA Labelling 98

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.

Communication 92

Communication 92

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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FDA Documentation 104

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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Hospital Pharmacy Europe

SEPTEMBER 26, 2023

While the healthcare super-regulator recognised the GPhC had made some improvements around its handling of FtP cases, it said it had serious concerns over the timeliness of its investigations. This is now the fifth consecutive year that the pharmacy regulator has failed to meet the PSA’s requirement for FtP timeliness – Standard 15.

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Documentation Hospitals 105

The FDA Law Blog

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 FDA Communication 59

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 99

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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Hospital Pharmacy Europe

JANUARY 18, 2024

While the IMscin001 trial was conducted within the hospital setting, SC atezolizumab may be administered by a healthcare professional outside of the hospital in a community care setting or at a patient’s home, depending on national regulations and health systems.

Hospitals 101

Hospitals 101

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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Communication Pharmaceutical Companies Pharmaceutical Companies Patient Care 98

ISPE

NOVEMBER 3, 2022

There is also opportunity for regulators to continue to share information through convergence that may make it possible to provide new therapies on a more global basis. This year’s panel featured regulators from multiple countries and regulatory authorities around the world: Nélio Cézar De Aquino. Global Regulatory Town Hall.

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Communication FDA Documentation Vaccines 98

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.

Vaccines 98

Vaccines Documentation 98

Omnicell

JANUARY 10, 2023

Bill helped draft the original law and has played a crucial role in shaping all the additional 340B legislation, regulations, and guidance that have been enacted since then. 2014: HRSA considered publishing a regulation that would have narrowed the definition of patient and placed other restrictions on the program.

Hospitals 96

Hospitals Insurance Omnicell Documentation 96

Hospital Pharmacy Europe

OCTOBER 19, 2023

Regulating against medicine misinformation is one of several recommendations to governments made by the International Pharmaceutical Federation (FIP) in a new statement of policy on the strategic development of medicines information.

Hospitals 52

Hospitals 52

The FDA Law Blog

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.

Documentation 64

Documentation FDA 64

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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Immunization FDA 90

Hospital Pharmacy Europe

NOVEMBER 9, 2023

Developed by FIP’s Regulators Advisory Group, the ’ Substandard and falsified medical products Regulatory self-assessment tool ’ is principally aimed at helping countries to self-assess the adequacy of their regulatory systems in supporting pharmacy interventions to prevent the harms of substandard and falsified (SF) medical products.

Hospitals 52

Hospitals Documentation 52

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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Vaccines Packaging 105

Hospital Pharmacy Europe

JANUARY 4, 2024

But, in a joint letter, the CPhO David Webb and GPhC chief executive Duncan Rudkin sought to reassure pharmacists that any such context would be considered ‘in the unlikely event’ that they were referred to the regulator. ‘We

Patient Care 52

Patient Care Hospitals 52

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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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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Compounding FDA 137

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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FDA Pharmaceutical Companies Pharmaceutical Companies 98

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.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies 98

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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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.

Communication 95

Communication 95

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.

Documentation 64

Documentation 64

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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Pharmaceutical Companies Pharmaceutical Companies Communication FDA 40

Hospital Pharmacy Europe

JANUARY 11, 2024

Last week the PDA questioned how the regulator will treat issues arising from workplace pressures in Scotland and Wales, after the GPhC issued a statement reassuring registrants in England that challenging contexts would be taken into account it in fitness to practise (FtP) proceedings.

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Community Pharmacies Hospitals 52

pharmaphorum

SEPTEMBER 8, 2022

The Digital Medicine Society (DiME) is today releasing a new set of open-access resources to advance the use of nocturnal scratch in the treatment of atopic dermatitis (AD). . It is hoped today’s event will serve as a “blueprint for the broader development and deployment of digital endpoints in medical product development”.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

The FDA Law Blog

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state.

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European Pharmaceutical Review

SEPTEMBER 28, 2022

In the 90-day review period stakeholders, including manufacturers, researchers and regulators, are encouraged to evaluate the definition and constituents of interest, as well as methods and specifications for identification, composition and contaminants.

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Labelling 97