FDA Law Blog: Biosimilars

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

Compliance 52

Compliance FDA FDA Approval Drugs 52

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Federal Court Orders Puerto Rico Pharmaceutical Distributor to Pay $12 Million in Connection with Alleged Failure to Report Suspicious Orders of Pharmaceutical Drugs and Other Controlled Substance Violations, Nov. 6, 2023 ( DOJ Press Release ). This post examines the Zarzamora pharmacy and prescribing red flags decision.

Pharmacy 139

Pharmacy Government Treatment Compliance 139

FDA Law Blog: Biosimilars

JUNE 17, 2024

Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. Last week, OPQ released its 6th Annual Report on the State of Pharmaceutical Quality. to maintain its gold standard of pharmaceutical quality. By Kalie E.

Pharmaceuticals 59

Pharmaceuticals FDA Production Drugs 59

Pharmaceutical Development Group

JANUARY 7, 2022

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. The seamless use of Data Standards also require compliance with Data Integrity Standards. Spanogle, Ph.D.

FDA 52

FDA FDA Approval Biosimilars Regulations 52

FDA Law Blog: Biosimilars

MARCH 4, 2024

Walsh will contribute her extensive expertise in FDA regulatory matters to a session titled “Global Ad Promo and Enforcement Insights,” addressing the complex landscape of advertising and promotion compliance on a global scale. Attendees can expect to gain practical strategies for compliance and enforcement, drawn from Ms.

Compliance 59

Compliance FDA Regulations Government 59

FDA Law Blog: Biosimilars

APRIL 8, 2024

Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. Last year, OPQ saved a more quantitative analysis of its efforts for the other yearly publication it put out, on the State of Pharmaceutical Quality. By John W.M.

FDA 59

FDA Pharmaceuticals Compliance Drugs 59

FDA Law Blog: Biosimilars

NOVEMBER 20, 2023

Claud — The word last week was that FDA is re-organizing the Office of Pharmaceutical Quality (OPQ) within the Center for Drug Evaluation and Research (CDER). By John W.M. It is the latest item on a long list of similar initiatives that have marked 2023.

Pharmaceuticals 59

Pharmaceuticals FDA Drugs Research 59

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

With over 26 years of dedicated service to the pharmaceutical and medical device industries, Ms. Walsh has garnered acclaim for her passionate efforts in assisting companies with preventing or responding to government investigations, conducting internal investigations to ensure compliance, and defending against DOJ prosecutions.

FDA 59

FDA Compliance Government International 59

Conversations in Drug Development Trends

JULY 9, 2024

The recent surge in GLP-1 treatments has ignited a profound shift in the pharmaceutical landscape, with more studies being announced than ever before. Glucagon also spares the GLP-1 effects potentially reducing side effects leading to increased compliance.

Clinical Research 52

Clinical Research Treatment Research Clinical Trials 52

FDA Law Blog: Biosimilars

AUGUST 14, 2023

OAI is FDA’s classification for facilities it deems to be in an unacceptable state of compliance. FDA also looked at how may of the Active Pharmaceutical Ingredients for those drugs were manufactured overseas. For those facilities manufacturing essential medicines deemed to be non-complex, 60% were located in these countries.

FDA 52

FDA Pharmaceuticals Compliance Production 52

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

With regulations varying significantly from one state to another, companies in these sectors often find themselves immersed in a labyrinth of compliance requirements. Sara is conveniently able to be a client’s one-stop point of contact for licensing needs.

Licensing 45

Licensing Licensing Pharmacy Regulations 45

FDA Law Blog: Biosimilars

JULY 18, 2023

Claud — The Office of Pharmaceutical Quality (OPQ), located within FDA’s Center for Drug Evaluation and Research (CDER), uses global inspection, surveillance, policy, and research activities to set quality standards for drugs. Consistent with that initiative, OPQ recently issued its 2022 Annual Report on the State of Pharmaceutical Quality.

FDA 52

FDA Licensing Licensing Laboratories 52

FDA Law Blog: Biosimilars

MARCH 24, 2024

PhRMA argued that Congress established the 340B drug discount program, imposed ceilings on prices drugmakers may charge certain healthcare facilities, specified what those facilities are, and provided compliance and enforcement mechanisms for manufacturers and covered entities. Code Ann. § 23-92-604(c)(1), (2) (Act 1103). McClain , No.

Pharmacy 59

Pharmacy Regulations Compliance Drugs 59

FDA Law Blog: Biosimilars

AUGUST 8, 2023

Lewis, Senior Regulatory Device & Biologics Expert — Please sing to the tune of “ Honesty ,” by Billy Joel: Nitrosamines, it’s such an ugly word, In pharmaceuticals’ impurity. Nitrosamines are hardly ever good, Now FDA has issued policy.

FDA 74

FDA Organic Chemistry Drugs Production 74

Agency IQ

MAY 3, 2024

voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Parliament voted on the extension to the diagnostic regulation (IVDR) compliance deadlines in plenary this week. The pharma reform package remains in E.U. On April 10, the E.U.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

FDA Law Blog: Biosimilars

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.

FDA 59

FDA Production Marketing Drugs 59

Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

FDA 40

FDA Science Regulations Production 40

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Hyman Phelps & McNamara received the following honors: Tier 1 FDA: Pharmaceutical Tier 1 FDA: Medical Device Additionally, eight professionals are included in LMG’s coverage: Robert A. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C. Dormer (Hall of Fame), Jeffrey N. Gibbs (Hall of Fame), John A. Gilbert , Gail H.

Science 40

Science Government FDA Regulations 40

FDA Law Blog: Biosimilars

JUNE 7, 2023

to transfer their patented pharmaceutical products to Medicare beneficiaries, for public use” at a government-dictated price that is a fraction of the drug’s value. First, Merck characterizes the program as a “ per se taking” without just compensation under the Fifth Amendment, because manufacturers are “force[d]. Complaint at 2.

Government 45

Government Compliance Drugs Production 45

FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

In addition, by the end of 2026 FDA will issue a report summarizing the activities performed by FDA’s Emerging Technology Team (ETT), which includes relevant representation from all FDA pharmaceutical quality functions. Finally, the ETT will establish program goals and performance measures for the ETP.

FDA 59

FDA International Production Drugs 59

Agency IQ

SEPTEMBER 1, 2023

pharmaceutical law ceased to apply to the U.K. The Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. from the E.U. on February 1, 2020 started a year-long transition period; The E.U.

International 40

International Regulations Production Marketing 40

FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

The Guidance which is the subject of this blogpost specifically provides that it is applicable to facilities which manufacture either generic drugs or active pharmaceutical ingredients for generic drugs.

FDA 45

FDA Drugs FDA Approval Packaging 45

The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. Treatment compliance rates across all our medicines have remained strong and continue to be slightly above expectations. ALEXION PHARMACEUTICALS, INC. ALEXION PHARMACEUTICALS, INC. Raised full year guidance, driven by increased revenue guidance of $350 million. 219.1. . .

Clinical Trials 40

Clinical Trials Trials Production Licensing 40

DrugBank

AUGUST 9, 2024

Investment Trends in Pharmaceutical Research and Development Investing in the pharmaceutical sector presents a unique set of challenges and opportunities; let’s examine them in more detail.  Pharmaceutical Market Analysis The global pharmaceutical market revenue in 2024 is projected to be 1.15

Pharmaceuticals 98

Pharmaceuticals Research Pharmaceutical Companies Clinical Trials 98

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

state pharmaceutical assistance programs). Audits and Compliance Monitoring: Using its discretionary authority under 42 U.S.C. CMS may similarly audit participating manufacturers up to once a year to monitor their compliance after a similar 60-day notice of a reasonable basis for the audit. Final Guidance at 15.

Compliance 105

Compliance Drugs Pharmacy Licensing 105

The Pharma Data

MAY 6, 2021

Another set of proposals is intended to support “a competitive and innovative EU pharmaceutical industry.” Specifically, wholesalers should conduct in-depth audits to verify full compliance with EU GDP requirements.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Production 52

Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

The Pharma Data

MAY 15, 2023

The Sandoz Board of Directors will have 10 members in total and 3 sub-committees: a Science, Innovation & Development Committee, a Human Capital & ESG Committee and an Audit, Risk & Compliance Committee. He will be Chair of the Audit, Risk & Compliance Committee of Sandoz. the world’s largest food company, since 2015.

Science 40

Science Doctors Government Pharmaceuticals 40

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials. The file will head to the Parliament for a vote next. Device news is unsettled.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

FDA 40

FDA Science Regulations Production 40

Agency IQ

MAY 31, 2024

.: Hands-on training course Webinar/Seminar ( OPEN ) EMA 6/03/2024 6/03/2024 EUCOPE’s Life Science Lectures – Episode Five (Joint Clinical Assessments) Webinar/Seminar ( OPEN ) EUCOPE 6/04/2024 6/04/2024 EUDAMED, the pathway to compliance Webinar/Seminar ( OPEN ) Team Person Responsible for Regulatory Compliance (TEAM-PPRC) 6/04/2024 6/04/2024 News (..)

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

Agency IQ

MARCH 29, 2024

Perhaps the most significant pharmaceutical news anticipated for April: the vote on the pharmaceutical legislation revision. This will include a number of conferences, webinars, and training sessions, as well as a long-awaited EMA workshop on psychedelics. A number of other HTA implementing regulations are also planned for Q2 2024.

Regulations 40

Regulations Production Clinical Trials Biosimilars 40

Agency IQ

OCTOBER 27, 2023

BY SIERRA MILAM, KARI OAKES, KIRSTEN MESSMER, PHD, RAC, COREY JASEPH, MS, RAC | OCT 25, 2023 5:20 PM CDT What we expect to be talking about in November: The proposed revised pharmaceutical directive and regulation: On November 7, the European Parliament Committee on the environment, public, health and food safety (ENVI) will be meeting to negotiate (..)

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

The Pharma Data

AUGUST 3, 2021

The company expects further volume declines for Forteo as a result of the anticipated entry of generic and biosimilar competition due to the loss of patent exclusivity in the U.S., 15% to 18% Numbers may not add due to rounding (a) includes costs related to business development transactions with Rigel Pharmaceuticals, Inc.,

Production 52

Production Marketing Research DNA 52