FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Walsh among an elite panel discussing “Around the World Hot Topics” – a session dedicated to exploring recent enforcement trends, regulator expectations, and best practices in white-collar crime law. The event is set to take place from March 4-6, 2024, in San Francisco, California.

59

59

PharmaState Academy

MARCH 19, 2024

The event garnered widespread acclaim for its focus on updating professionals on new-age skill sets and gaining in-depth knowledge of trending topics to address today’s day and age challenges in the sales and marketing realm of the Pharma Industry. The trending topics were discussed in four Talks & presentation formats.

Communication 40

Communication Pharmaceutical Companies Pharmaceutical Companies 40

Express Pharma

JULY 14, 2023

The platform imparted informative sessions on wide range of topics, including investigational skills for counterfeit drugs, legal drafting, blood center inspections, medical devices rules, good regulatory practices. Founder/Member(s) of this association Lalit Goel and Sh. Rakesh Dahiya along with Gen.

89

89

Pharma in Brief

JANUARY 8, 2024

While recognizing the potential benefits of AI, the Court also underscores the risks associated with “deepfakes” and potential fabrication of legal authorities. Court Policy commits to consultation on use of AI While the Court’s Notice is directed to parties and the legal profession, its Policy addresses the Court’s own use of AI.

Documentation 52

Documentation 52

FDA Law Blog: Biosimilars

NOVEMBER 30, 2023

The speaker faculty of top FDA regulatory authorities will share critical insights on foreign and domestics inspections, digital health, DOJ’s compliance guidelines, and data privacy, among many other topics. The conference will also include its annual panel discussion with FDA’s Center Compliance Directors.

Communication 59

Communication 59

Drug Channels

JANUARY 22, 2024

Join your peers one day early on March 18th for 3 hot topic, intensive workshops: Advocacy and Engagement Alternative Funding Programs Product Launch and Commercialization Vital insights from industry’s leading access and affordability experts, including: Corey Ford, MHA, Vice President of Reimbursement and Policy Insights, Cencora Kevin L.

52

52

FDA Law Blog: Biosimilars

MARCH 21, 2024

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant. By John W.M.

Packaging 64

Packaging Communication 64

Pharma Leaders

JUNE 13, 2023

The FDA has “sufficient legal authority right now to require postmarket efficacy studies to verify clinical benefit and to impose expedited withdrawal more expansively than it has to date,” they write, “allowing [the agency] to avoid the current regulatory limbo between traditional and accelerated approval.” Related Topics

40

40

Dr. Neal Smoller

MARCH 31, 2023

Topics Discussed What is Ozempic? Legality and FDA approval of the drugs The science behind Ozempic Who can safely take Ozempic? Ali Watson and Dr. Benjamin Jolley chime in with their unparalleled expertise to shed some light on how Ozempic & Wegovy are helping folks shed the pounds. What is Wegovy? Who should not take Ozempic?

40

40

Pharmaceutical Technology

MAY 10, 2023

Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. Gilead markets both Truvada and its successor Descovy.

Pharmaceutical Companies 105

Pharmaceutical Companies Pharmaceutical Companies 105

Pharma and Life Sciences Blog

MARCH 22, 2024

The benefits are being applied throughout firms, from finance and legal departments to supply chains and procurement. Webinar Topic: Reimagining Procurement and Supply Chain Functions with AI Date : Tuesday April 18, 2024 Time : 10 a.m. The technology’s ability to automate tasks has helped business leaders.

Communication 40

Communication 40

Drug Channels

MARCH 29, 2021

The 2021 event has a content-rich agenda , providing the most up-to-date content and topics based on the ever-changing political and regulatory environment, fresh perspectives from small to big pharma and more interaction in the virtual environment. Up-To-Date Content.

52

52

Drug Channels

MARCH 29, 2021

The 2021 event has a content-rich agenda , providing the most up-to-date content and topics based on the ever-changing political and regulatory environment, fresh perspectives from small to big pharma and more interaction in the virtual environment. Up-To-Date Content.

52

52

Pharmaceutical Technology

JULY 6, 2022

In a press statement, CureVac said: “CureVac does not seek an injunction nor intend to take legal action that impedes the production, sale or distribution of Comirnaty by BioNTech and its partner Pfizer.”. Topic sponsors are not involved in the creation of editorial content.

Vaccines 72

Vaccines 72

PharmaState Academy

DECEMBER 12, 2023

Milind Antani, Lead Pharmaceuticals, Life Science & Healthcare Practice, Nishith Desai Associates – Legal & Tax Counselling Worldwide, and; Ms. NDA cautioned against making price comparisons with competitors and emphasized the importance of focusing on demonstrating value for money.

Communication 52

Communication Hospitals Labelling 52

Board Vitals - Pharmacist

NOVEMBER 28, 2022

The following topics are on the USMLE Step 1 : . Advanced Topics in Anesthesiology 50%. The ABA ADVANCED Exam consists of 200 multiple choice questions that cover the following topics: . The Medical College Admission Test (MCAT) is a required exam for those looking to enter medical school. USMLE Step 1.

Medical Schools 98

Medical Schools Communication Immunity Immunization 98

Drug Channels

JUNE 26, 2023

When you join Informa for this groundbreaking think-tank, you’ll find yourself in the company of experts from health systems, pharma/biotech manufacturers, integrated delivery networks, payers, and providers to hear novel case studies, regulatory updates and innovative models aimed at developing and maintaining collaborative, patient-centered partnerships. (..)

Biosimilars 63

Biosimilars 63

PharmaState Academy

NOVEMBER 16, 2023

Topics included the transition from illness to wellness, the growing acceptance of digital healthcare solutions, and the infusion of technology into pharmaceutical marketing. These quizzes were tailored to the panel’s topic, adding an element of fun and learning. Participants used their smartphones to scan a QR code and join in.

Communication 52

Communication 52

PharmaState Academy

NOVEMBER 17, 2023

Compliance and Credibility: The importance of adhering to regulatory and legal guidelines is underscored. This insightful panel discussion navigates through a spectrum of topics, from digital transformation and training to patient-centricity and real-world evidence.

Communication 52

Communication 52

pharmaphorum

AUGUST 26, 2020

“They designed pre-printed prescription forms with multiple options of pre-determined categories of medical conditions with the physician marking boxes for medications, often high-dollar cost topical creams and ointments,” claims Humana and its legal counsel.

120

120

Pharmaceutical Technology

APRIL 6, 2023

.” Foley Hoag served as legal counsel to Ginkgo for the transaction, while Ropes & Gray was the legal advisor to StrideBio. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

Eye on FDA

JULY 19, 2021

You may recall from the last posting on this topic at the beginning of the year, during 2020, FDA had a lot to say – a real lot, and that isn’t surprising given the agency’s role in facilitating treatments, diagnostics and vaccines to respond to COVID. This year there were only 67 Coronavirus Updates in the first half.

Labelling 93

Labelling Communication Vaccines 93

Board Vitals - Pharmacist

SEPTEMBER 1, 2022

Tests knowledge of legal and ethical implementations for healthcare and technology; nonpharmacologic intervention and treatment selection; pharmacotherapeutic intervention selection; regulatory guidelines; and APRN scope and standards. Implementation. Evaluation. What subjects are covered on the new FNP Exam?

Immunity 52

Immunity Immunization 52

Drug Channels

MARCH 6, 2023

Attorney's Office for the Districts of MA and NJ , and Viatris You'll take a deep dive into the hottest topics keeping you up at night, including Drug Pricing Transparency Pressures DOJ Drug Pricing Transparency Priorities Legal Updates on Authorized Generics and the U.S.

Drug Pricing 84

Drug Pricing 84

Drug Channels

APRIL 11, 2021

Vice President, Legal and Chief Compliance Officer , Acceleron Pharma Inc. Drug Channels readers save 10% off the current registration rate with promo code 21PSSDC10.* Register today. Attorney’s Office, Eastern District of New York Rahul Khara, Pharm.D., Amy Wilson, Head, U.S.

Specialty Pharmacies 40

Specialty Pharmacies Drug Pricing 40

Drug Channels

OCTOBER 15, 2023

Drug Channels readers will save 10% off when they use code 23DRCH10 and register prior to November 10, 2023.*

Drug Pricing 56

Drug Pricing Biosimilars 56

Pharmaceutical Technology

MAY 17, 2023

While negotiating drug prices is common practice in other major markets, CMS had not previously held the legal authority to do so. Insulin affordability has continued to prove a hot button topic as major pricing reforms are on the way.

Drug Pricing 52

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Drug Development 52

National Association of Boards of Pharmacy

APRIL 3, 2024

Ask the following questions: Are there policies or specific procedures about this topic? Adding inspection readiness and training as a regular subject will familiarize your staff with these topics and instill confidence in your team. Was the task specified within the procedures? These ideas are not requirements prior to on-site visits.

Documentation 45

Documentation 45

InCrowd

JUNE 12, 2023

After taking report, I noticed the legal name attached to her medical record was not consistent with what I perceived as her gender expression. As I continue to absorb wisdom from my older and more experienced colleagues, I’ve pushed myself to start conversations about topics like pronouns and gender-affirming care.

Medical Records 52

Medical Records Compounding 52

Eye on FDA

AUGUST 18, 2020

The agency now issues daily updates on the topic. Legal – These announcements include warnings to companies and court actions such as consent decrees. During the first half of the year, FDA issued releases about 14 legal actions, somewhat less than last year when it issued 19.

Communication 61

Communication Documentation Labelling 61

Drug Channels

APRIL 18, 2022

Ensure you are at the table with leaders from across industry as they collaborate on and discuss the most timely and crucial topics, including industry standards for patient assistance, changing legal trends, tools and technologies to empower patients to better manage OOP costs, next-generation models for assistance, and so much more.

Specialty Pharmacies 56

Specialty Pharmacies Hospitals 56

Pharma in Brief

JANUARY 10, 2024

As you start the new year, allow us to recap 2023’s important legal and regulatory developments for Canadian pharma. The most significant legal development in 2023 was the introduction of a system of patent term adjustment ( PTA ). We also flag what to watch out for in 2024. Artificial intelligence.

Drug Pricing 52

Drug Pricing Documentation Biosimilars Vaccines 52

Drug Channels

JULY 12, 2021

Hear multi-stakeholder perspectives on the most pressing topics and attend tailored content offerings based on your individual needs, including: Executive Outlook: The Intersection on Access and Affordability for Health Policy Build on the ACA Trends to Reduce Coverage Gaps and Disruptions Enforcement Update: Understand DOJ Enforcement Priorities for (..)

40

40

Eye on FDA

AUGUST 10, 2023

While the FDA in Brief documents covered only one topic, the FDA Roundup can cover several and includes an update on COVID-related activities, meaning that while the overall volume of releases is down, the overall volume of information may, in fact, be up. Did they speak Spanish?

Communication 80

Communication Documentation 80

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

In short, Voluntary Consensus Standards (VCS) are intended to be exactly what the name conveys – standards that are adopted by consensus and are not mandatory (not legal or regulatory requirements). These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand.

Packaging 59

Packaging Documentation Labelling Communication 59

FDA Law Blog: Biosimilars

APRIL 25, 2023

However, FDA’s legal standing to insist on cybersecurity features, especially within the substantial equivalence paradigm, has been questionable. Now, with explicit statutory authority, FDA’s push for cybersecurity has a firm legal footing. We have recently blogged on this topic (“ Is my software a medical device? ”).

Documentation 105

Documentation Labelling Communication 105

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. We’ve published two articles on the topic — one examining the concept of program optimization itself, and the other exploring the impact contract pharmacy relationships can have on program optimization.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Pharmaceutical Manufacturing 52