Pharmacy Technician Pulse

5 Things To Know About Antimicrobial Stewardship Regulatory Standards

IDStewardship

APRIL 13, 2023

In this article an infectious diseases pharmacist with experience managing antimicrobial stewardship programs discusses antimicrobial stewardship regulatory standards Authored by: Timothy P. The regulatory body the Center for Medicare and Medicaid Services (CMS) is one of these departments. Gauthier, Pharm.D.,

Hospitals

Hospitals Documentation Communication Patient Care

Selkirk Pharma: Adapting to regulatory shifts and market demand

Outsourcing Pharma

APRIL 22, 2024

Ahead of CPHI North America, we caught up with Lisa Stiles, director, business development at Selkirk Pharma, an exhibitor at the event, to find out how the CMO is navigating regulatory changes, challenges and more.

Outsourcing regulatory activities in pharma

European Pharmaceutical Review

JANUARY 3, 2024

Outsourcing has become a necessity for many pharmaceutical companies; even the outsourcing of regulatory functions has grown over the past several years and is expected to increase steadily in future. 1 Collectively, Europe and the US are anticipated to account for 60 percent of the global outsourcing regulatory affairs demand to 2032.

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies

Endotoxin testing: the international regulatory landscape

European Pharmaceutical Review

APRIL 2, 2024

Pharmacopoeia guidance on recombinant BET methods Currently, the regulatory landscape surrounding the use of (rFC) and (rCR) can be complex and confusing. Additionally, there are positive regulatory developments on the horizon. It is important to understand the guidance provided by different pharmacopoeias.

Method Validation

Method Validation Medical Schools

STAT+: Nuclear Regulatory Commission advisers beset by conflicts of interest, report finds

STAT

APRIL 4, 2024

The report, released on March 26 and conducted by the Nuclear Regulatory Commission’s (NRC) Office of the Inspector General, identified conflicts of interest involving two members of the Advisory Committee on the Medical Uses of Isotopes (ACMUI), a group of experts that advises the NRC. The oversight division of a U.S.

Prior authorization and other regulatory burdens have increased since last year, practices tell MGMA

Fierce Healthcare

NOVEMBER 13, 2023

Nine in 10 polled medical practices say their regulatory burden has increased over the past year with prior authorization, audits and appeals, the Medicare Quality Payment Program (QPP) and require | The latest annual poll of practices' regulatory burden outlined prior authorization, audits and appeals, Medicare QPP and other leading pain points (..)

Regulatory revision essential for bioprocess IIoT adoption

European Pharmaceutical Review

JANUARY 4, 2024

concluded that updating regulatory guidelines and developing relevant standards and guidelines to accommodate the development of these systems “are essential to reduce the associated costs and allow off-the-shelf solutions to be developed.” Borgosz et al. To facilitate the adoption of IIoT systems in bioprocessing, Borgosz et al.

Ethical and Regulatory Issues with Weight Loss Companies

PharmExec

APRIL 9, 2024

In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, talks about the ethical and regulatory problems weight loss companies like WW, Noom, and Ro present.

Opinion: STAT+: The problem with potential changes to the biosimilar regulatory framework

STAT

SEPTEMBER 26, 2023

Since the Biologics Price Competition and Innovation Act of 2009 created a regulatory pathway for biosimilar medicine review in the U.S., This progress is due, in part, to thoughtfully considered, scientifically robust regulatory standards, which have instilled confidence among health care providers and patients while protecting safety.

FDA

Regulatory, Compliance and Quality Challenges, Learnings, and Future Opportunities

ISPE

SEPTEMBER 15, 2023

The Regulatory, Compliance, and Quality sessions, promise to be a comprehensive exploration of the vital topics shaping the pharmaceutical landscape. However, it also poses intricate regulatory challenges, as it requires navigating a complex terrain of both pharmaceutical and medical device regulations.

FDA

FDA Pharmaceutical Companies Pharmaceutical Companies Patient Care

European regulatory perspective on nitrosamine mitigation strategies

European Pharmaceutical Review

AUGUST 29, 2023

Experts at the European Medicines Agency (EMA) have provided a regulatory perspective on risk factors and mitigation strategies for nitrosamine impurities in human drug products. The European regulatory body amended Q&A 10 and added three appendices. Cioc et al.

2023 Patient Access: State Legal and Regulatory Environment Survey Objectives and Strategies

PharmExec

APRIL 22, 2024

In this Pharmaceutical Executive video interview, Jon Hamrick, Partner, Curatio Scientia Advisors and Jon Rawlson, President & Founder, Armory Hill Advocates, discusses how they went about testing their various hypotheses for the 2023 Patient Access: State Legal and Regulatory Environment Survey and how they collected the data.

Pioneering malaria vaccine gains regulatory clearance

European Pharmaceutical Review

APRIL 25, 2023

Regulatory] approval of the [R21/Matrix-M ] malaria vaccine in Ghana was the first in the world” Approval of the malaria vaccine in Ghana was the first in the world. Ghana’s regulatory approval is a vital step in helping to reduce over half a million malaria-related deaths annually, stated the institution.

Vaccines

Vaccines Immunization FDA

How to advance more late-stage neuroscience drugs to regulatory approval

pharmaphorum

DECEMBER 1, 2023

How to advance more late-stage neuroscience drugs to regulatory approval Mike.Hammerton Fri, 01/12/2023 - 09:00 Bookmark this

Psychedelic research: evaluating the fast-evolving regulatory roadmap

European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades.

Compounding

Compounding Controlled Substances FDA Patient Care

Asia-Pacific Regulatory & Industry Views on Drug Shortage Prevention

ISPE

MAY 22, 2023

Regulatory speakers were Lisa Hedman, Group Lead for the Division of Supply and Access to Medicines of the World Health Organization (WHO); and Joyce Cirunay, Director IV of the Center for Drug Regulation and Research at the Philippines FDA. Hustead Executive Director, Regulatory Affairs Merck & Co.,

Communication

Communication FDA

Nonprescription Drug and Cosmetic Regulatory Overhaul: What Pharmacists Need to Know

Pharmacy Times

APRIL 24, 2023

The crucial role of self-care pharmacy practice requires that pharmacists develop a robust understanding of the implications of the current and proposed regulatory changes for nonprescription drugs.

Susan Schniepp of Regulatory Compliance Associates Discusses the Impact of QMS on Quality Maturity at INTERPHEX 2024

BioPharm

APRIL 17, 2024

At INTERPHEX 2024, Susan Schniepp, distinguished fellow, Regulatory Compliance Associates, and co-chair of board of directors, Parenteral Drug Association, explores the impact of QMS on quality maturity.

New UK point of care manufacturing regulatory framework

European Pharmaceutical Review

JANUARY 27, 2023

The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Clear regulatory expectations and allowing easier product development.

Hospitals

Using GenAI as a Co-Pilot for Regulatory Intelligence

PharmExec

FEBRUARY 6, 2024

GenAI is on the precipice of breaking new ground in regulatory intelligence; making strategists more efficient by alleviating challenges, streamlining regulatory research and submission processes.

EMA publishes mid-point regulatory science strategy report

European Pharmaceutical Review

MARCH 24, 2023

The European Medicines Agency (EMA) has published a report summarising the mid-point achievements of its Regulatory Science Strategy (RSS) to 2025. Initially published in March 2020, the strategy provides a plan for advancing regulatory science over a five-year period.

Navigating Regulatory Compliance in the Pharmaceutical Industry

Pharma Mirror

NOVEMBER 7, 2023

Navigating regulatory compliance in the pharmaceutical industry is crucial to ensure the safety, efficacy, and quality of pharmaceutical products. Good Manufacturing Practices The post Navigating Regulatory Compliance in the Pharmaceutical Industry appeared first on Pharma Mirror Magazine.

FDA

FDA: CBD Requires Separate Regulatory Pathway from Dietary Supplements, Food

Drug Topics

JANUARY 27, 2023

The agency intends to work with Congress to create a pathway that balances the desire for access with regulatory oversight and risk management.

FDA

Regulatory Review: Legislative Actions Poised to Impact Pharmacy Inventory Management

Drug Topics

APRIL 13, 2023

Recent legislation and regulatory updates will impact pharmacy inventory management in the coming months.

Navigating Regulatory Constraints in Pharma Advertising

Pharma Marketing Network

SEPTEMBER 19, 2023

Navigating regulatory constraints in pharma advertising is essential for success in this competitive industry. Understanding Regulatory Requirements In order to comply with regulatory requirements, it is important to understand the relevant laws and regulations.

How pharma can improve regulatory compliance with AI-based technology

pharmaphorum

AUGUST 1, 2023

How pharma can improve regulatory compliance with AI-based technology Mike.Hammerton Tue, 01/08/2023 - 08:00 Bookmark this

Telehealth companies that provide abortion pills grapple with regulatory uncertainty

STAT

APRIL 25, 2023

Telehealth providers stay nimble amid regulatory uncertainty Read the rest… You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday.

Hospitals

Hospitals FDA

Pfizer obtains regulatory approvals for $43bn Seagen acquisition

Pharmaceutical Technology

DECEMBER 13, 2023

Pfizer has obtained all necessary regulatory approvals for concluding the acquisition of biotechnology company Seagen for $43bn in cash.

ISPE’s Regulatory Commenting Process

ISPE

FEBRUARY 14, 2023

ISPE’s Regulatory Commenting Process Trudy Patterson Tue, 02/14/2023 - 16:19 iSpeak Blog iSpeak ISPE’s Regulatory Commenting Process Wendy McGhee 14 February 2023 What is Commenting? ISPE’s commenting process is overseen by ISPE’s Regulatory Quality Harmonization Committee (RQHC) and managed by ISPE regulatory staff.

Documentation

Documentation Communication

Innovation and access: Improving Europe’s pharmaceutical regulatory framework

pharmaphorum

JANUARY 12, 2022

Only a regulatory framework that “embraces a culture of excellence and innovation” will make Europe a world leader in life sciences and ensure people can reap the benefits of life-changing new treatments. The stated aim of the EC legislation review is to build a “future-proof and crisis-resistant medicines regulatory system”.

FDA

FDA Vaccines

Regulatory Due Diligence Becomes More Critical in a “Hot” Year for Deals in the FDA Space

The FDA Law Blog

JANUARY 8, 2024

In a “hot” deal market, its worthwhile reiterating the fundamentals of regulatory due diligence that don’t change, no matter how attractive the deal or how short the window is to seize the opportunity. Having the right diligence team is critical because proper risk assessment of regulatory risk requires a broad range of expertise.

FDA

QMSR Harmonization Curiously Missing from Spring 2023 Regulatory Agenda

The FDA Law Blog

MARCH 6, 2023

The proposed rule was published on February 23, 2022 and was first heralded by FDA in 2018 and introduced in the Spring 2018 regulatory agenda. Keen observers may have noticed that in the most recent semiannual regulatory agenda , neither the Quality System Regulation nor the Quality Management System Regulation is referenced.

FDA

Novo's high-dose Rybelsus win tees up regulatory filings—and new rivalries

Fierce Pharma

MARCH 27, 2023

Novo's high-dose Rybelsus win tees up regulatory filings—and new rivalries esagonowsky Mon, 03/27/2023 - 09:19

Kevin Hawkins appointed as Reacta’s head of regulatory affairs

Pharmafile

JULY 3, 2023

Reacta Healthcare, an early-stage food allergy diagnostic company, has announced the appointment of Kevin Hawkins as head of regulatory affairs. He has […] The post Kevin Hawkins appointed as Reacta’s head of regulatory affairs appeared first on Pharmafile.

Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type

Fierce Pharma

MAY 17, 2023

Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type aliu Wed, 05/17/2023 - 09:41

FDA

Navigating Regulatory Challenges in Pharma Marketing: Best Practices

Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing.

Packaging

Packaging Labelling Communication Pharmaceutical Companies

HP&M Director Anne Walsh to Share Global Ad Promo Insights at the DIA Advertising and Promotion Regulatory Affairs Conference

The FDA Law Blog

MARCH 4, 2024

(HP&M), is pleased to announce that Director Anne Walsh will be speaking at the DIA Advertising and Promotion Regulatory Affairs Conference. This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. Before joining HP&M, Ms.

FDA

MHRA cuts could affect UK regulatory decisions, say unions

pharmaphorum

SEPTEMBER 8, 2021

A 20% to 25% reduction in staffing at the UK Medicines and Healthcare products Regulatory Agency (MHRA) risks undermining the ability of the authority to fulfil its role, according to trade unions. ” The post MHRA cuts could affect UK regulatory decisions, say unions appeared first on.

Japan grants emergency regulatory approval for Shionogi’s Covid-19 drug

Pharmaceutical Technology

NOVEMBER 22, 2022

The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted emergency regulatory approval for Shionogi ’s new anti-SARS-CoV-2 drug, Xocova (ensitrelvir fumaric acid, S-217622), for Covid-19. The post Japan grants emergency regulatory approval for Shionogi’s Covid-19 drug appeared first on Pharmaceutical Technology.

RNA-LNPs: Navigating the regulatory challenges

Pharmaceutical Technology

AUGUST 14, 2023

We discuss why demand for ionizable lipid mixes for delivery and target validation has surged and how the regulatory approval process is evolving.

The Evolution of the CBD Regulatory Landscape

Drug Topics

SEPTEMBER 14, 2022

No federal agency has taken charge of regulating cannabidiol products, leaving decisions up to the individual states.

The Ever-Changing Regulatory & Quality Landscape with Aseptic Processing

ISPE

JANUARY 30, 2023

The Ever-Changing Regulatory & Quality Landscape with Aseptic Processing Trudy Patterson Mon, 01/30/2023 - 10:54 iSpeak Blog iSpeak The Ever-Changing Regulatory & Quality Landscape with Aseptic Processing Michael G. Make plans now to attend the and take advantage of hearing from Industry and Regulatory experts.

FDA

Regulatory tracker: Menarini's Korserdu becomes UK's first new endocrine cancer fighter in decades

Fierce Pharma

JANUARY 3, 2024

Welcome to 2024's regulatory tracker for Fierce Pharma. | In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

Why a 'fundamental shift' in regulatory submissions is on the way

PharmaVoice

JULY 11, 2022

Deloitte's senior manager of R&D and regulatory practices explains how technology and strategy must converge to smooth out the bulky drug approval process.

5 Things To Know About Antimicrobial Stewardship Regulatory Standards

Selkirk Pharma: Adapting to regulatory shifts and market demand

Trending Sources

Outsourcing regulatory activities in pharma

Endotoxin testing: the international regulatory landscape

STAT+: Nuclear Regulatory Commission advisers beset by conflicts of interest, report finds

Prior authorization and other regulatory burdens have increased since last year, practices tell MGMA

Regulatory revision essential for bioprocess IIoT adoption

Ethical and Regulatory Issues with Weight Loss Companies

Opinion: STAT+: The problem with potential changes to the biosimilar regulatory framework

Regulatory, Compliance and Quality Challenges, Learnings, and Future Opportunities

European regulatory perspective on nitrosamine mitigation strategies

2023 Patient Access: State Legal and Regulatory Environment Survey Objectives and Strategies

Pioneering malaria vaccine gains regulatory clearance

How to advance more late-stage neuroscience drugs to regulatory approval

Psychedelic research: evaluating the fast-evolving regulatory roadmap

Asia-Pacific Regulatory & Industry Views on Drug Shortage Prevention

Nonprescription Drug and Cosmetic Regulatory Overhaul: What Pharmacists Need to Know

Susan Schniepp of Regulatory Compliance Associates Discusses the Impact of QMS on Quality Maturity at INTERPHEX 2024

New UK point of care manufacturing regulatory framework

Using GenAI as a Co-Pilot for Regulatory Intelligence

EMA publishes mid-point regulatory science strategy report

Navigating Regulatory Compliance in the Pharmaceutical Industry

FDA: CBD Requires Separate Regulatory Pathway from Dietary Supplements, Food

Regulatory Review: Legislative Actions Poised to Impact Pharmacy Inventory Management

Navigating Regulatory Constraints in Pharma Advertising

How pharma can improve regulatory compliance with AI-based technology

Telehealth companies that provide abortion pills grapple with regulatory uncertainty

Pfizer obtains regulatory approvals for $43bn Seagen acquisition

ISPE’s Regulatory Commenting Process

Innovation and access: Improving Europe’s pharmaceutical regulatory framework

Regulatory Due Diligence Becomes More Critical in a “Hot” Year for Deals in the FDA Space

QMSR Harmonization Curiously Missing from Spring 2023 Regulatory Agenda

Novo's high-dose Rybelsus win tees up regulatory filings—and new rivalries

Kevin Hawkins appointed as Reacta’s head of regulatory affairs

Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type

Navigating Regulatory Challenges in Pharma Marketing: Best Practices

HP&M Director Anne Walsh to Share Global Ad Promo Insights at the DIA Advertising and Promotion Regulatory Affairs Conference

MHRA cuts could affect UK regulatory decisions, say unions

Japan grants emergency regulatory approval for Shionogi’s Covid-19 drug

RNA-LNPs: Navigating the regulatory challenges

The Evolution of the CBD Regulatory Landscape

The Ever-Changing Regulatory & Quality Landscape with Aseptic Processing

Regulatory tracker: Menarini's Korserdu becomes UK's first new endocrine cancer fighter in decades

Why a 'fundamental shift' in regulatory submissions is on the way

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