Pharmaceutical Technology

JANUARY 16, 2023

The US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations to the company’s zevor-cel in 2019. In October last year, CARsgen submitted a new drug application (NDA) for CT053 to China’s National Medical Products Administration (NMPA).

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Pharmaceutical Technology

MARCH 30, 2023

On March 29, the US Food and Drug Administration (FDA) granted approval for the first nonprescription, “over-the-counter” (OTC) naloxone nasal spray, Narcan. The overdose death rate in the US increased more than 250% from 1999 to 2019, as per a Canada-US joint white paper on substance use and harms.

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Pharmaceutical Technology

JANUARY 31, 2023

The gene therapy received Orphan Drug and Fast Track designations from the US Food and Drug Administration (FDA). It includes a recombinant AAVrh10 vector that expresses a micro ribonucleic acid (miRNA) which reduces the expression of SOD1 to slow down or reverse ALS progression in SOD1 mutation patients.

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Pharmaceutical Technology

MARCH 8, 2023

Currently, there are six CAR T cell therapies that received approval from the US Food and Drug Administration (FDA) and approximately 560 programmes in ongoing studies. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

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Communication FDA 97

pharmaphorum

AUGUST 5, 2020

There’s already plenty of support from regulators for virtual or ‘decentralised’ trials, including from former FDA Commissioner Scott Gottlieb who said last year that the agency was encouraging adoption of this approach to make trials more “agile and efficient”, as well as patient-centric.

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The FDA Law Blog

APRIL 8, 2024

Drug shortages have been a scourge for FDA , both as they negatively affect consumers and FDA’s reputation. From that lack of detail, it would appear that FDA thinks of Good Manufacturing Practice (cGMP) compliance as a timeless and ecumenical pursuit, following the well-worn path laid out in its now-18 year old guidance.

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ISPE

OCTOBER 1, 2023

Effective and Efficient Cleaning Weighing in Regulated Environments Trudy Patterson Sun, 10/01/2023 - 11:30 White Paper — Sponsored Content Effective and Efficient Cleaning Weighing in Regulated Environments 1 October 2023 Cross-contamination in manufacturing impacts product quality and may even lead to product recalls.

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The FDA Law Blog

JANUARY 5, 2023

In 2022, the chief regulating entities—FDA, FTC, and DOJ—all continued to forge policies to help bridge the rapidly moving waters between traditional regulatory concerns about safety and effectiveness on one side and cybersecurity, data privacy, and identity integrity on the other. FDA has shown a willingness to intervene in this space.

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The FDA Law Blog

NOVEMBER 1, 2022

FDA/CBER (the Agency) provided an overview of CMC challenges for CART development (e.g., Use of automation does not allow for bypassing FDA requirements with respect to method transfer comparability. Opportunity for feedback from FDA if provided pre-BLA.

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ISPE

NOVEMBER 1, 2022

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. The US FDA monitors quality, and Kopcha traced changes in regulation of quality over the years. FDA Activities in Support of Quality. Tue, 11/01/2022 - 06:49.

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The FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. FDA interprets the term “pattern” to mean “multiple, sequential, or repeated measurements of a signal or from a signal acquisition system.”

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Pharmaceutical Technology

DECEMBER 16, 2022

The CAR-T cell therapy received Orphan Drug Designation from the Food and Drug Administration (FDA) and a Breakthrough Designation from the China Center of Drug Evaluation (CDE). In the registrational trial, the therapy showed a complete success rate of drug production in r/r B-ALL patients.

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Pharmaceutical Technology

DECEMBER 14, 2022

In October, the US Food and Drug Administration (FDA) granted approval for the company’s Boostrix for use in pregnant women during their third trimester to prevent pertussis in newborn infants. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

JANUARY 20, 2023

The CEO illustrated his point, by discussing that in June, the Center for Biologics Evaluation and Research (CBER), at the FDA, requested new vaccines for the BA.5 In a panel discussion on the “State of the Pandemic” , Bancel said, “We’ve shown this summer that we are able to adapt to different variants very quickly”. 5 Omicron variant.

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ISPE

JUNE 14, 2023

This year, Dr. Jennifer Maguire joined from FDA CDER’s Office of Quality Surveillance (OQS) to provide a keynote presentation on Quality Management Maturity (QMM) and the FDA’s ongoing QMM program development. Furthermore, any QMM rating program will be voluntary whereas Quality Metrics are considered mandatory under FDA regulations.

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ISPE

NOVEMBER 3, 2022

The regulatory keynote was delivered by Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research (CBER), US FDA. Marks outlined some concepts that the FDA is thinking about that could help move in this direction, such as developing a “cookbook” to standardize bespoke product development and manufacturing.

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The FDA Law Blog

JANUARY 4, 2023

As previously m entioned , sponsors can interact with FDA in the town hall by submitting questions in advance or by asking a question live during the meeting. The Agency repeatedly stated and strongly recommends sponsors engage with FDA prior to submitting the IND. The workshop is also discussed in Cell & Gene here and here.

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Pharmaceutical Technology

OCTOBER 28, 2022

For companies in the US, if the results show bioequivalence, an abbreviated new drug application (ANDA) containing the results is sent to the FDA to review and potentially approve. For more information on this, please download our white paper. For more information, please download our white paper.

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pharmaphorum

JUNE 29, 2022

Non-COVID prescription medicines didn’t stop launching during the pandemic — approvals by both the FDA and the EMA were, in fact historically high in both 2020 and 2021. The scope of the problem. She has been vice resident, European Marketing and Thought Leadership in IQVIA for 12 years.

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Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. The vaccine, which recently received an FDA Breakthrough Therapy designation, had an efficacy of 83.7% per 100,000.

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Pharma Marketing Network

FEBRUARY 5, 2025

Engage in scientific dialogues by sharing white papers and expert opinions. Compliance Challenges and How to Overcome Them Pharma marketing on social media comes with strict regulations , including: FDA and EMA guidelines restricting direct-to-consumer advertising. Pharma brands can: Join relevant hashtags (e.g.,

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Pharma Marketing Network

DECEMBER 19, 2024

Education and Training: Provide resources like webinars or white papers to engage HCPs effectively. Solution: Partner with legal and compliance teams to ensure all campaigns adhere to FDA and HIPAA guidelines. By defining these audiences clearly, pharma brands can create messages that resonate and build trust.

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ISPE

JULY 19, 2023

This includes ensuring maturity levels for all operating model elements follow the five general maturity levels defined by the FDA: 1–Initial, 2–Developmental, 3–Defined, 4–Managed, and 5–Optimized. A main area to consider is connections, such as: Bridging industry 4.0 to a pharma-specific Pharma 4.0™ to a pharma-specific Pharma 4.0™

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PharmaShots

FEBRUARY 14, 2023

For example, if you develop a medicine that can treat diabetes and you desire FDA approval, the path is standardized and clearly laid out. In this case, the FDA has the framework to evaluate that evidence and confidently provide an outcome. To get clearance or approval from the FDA, manufacturers must assess the risk of the device.

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PharmaShots

FEBRUARY 14, 2023

For example, if you develop a medicine that can treat diabetes and you desire FDA approval, the path is standardized and clearly laid out. In this case, the FDA has the framework to evaluate that evidence and confidently provide an outcome. To get clearance or approval from the FDA, manufacturers must assess the risk of the device.

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ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

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ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

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Documentation Dosage Packaging Communication 52

The FDA Law Blog

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response.

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ISPE

AUGUST 29, 2022

In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. The FDA has also offered both early dialogue and training to share knowledge and experience with the industry, providing an excellent example for other regulators to follow.

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ISPE

SEPTEMBER 11, 2023

FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” www.raps.org/news-and-articles/news-articles/2023/3/fda-official-warns-manufacturers-of-common-problem 25 US Food and Drug Administration Center for Drug Evaluation and Research. September 2022. 25%20from%202022%20to%202027 24 Eglovitch, J. 7 March 2023.

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The FDA Law Blog

JUNE 19, 2023

Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. The announcement in the Unified Agenda of a planned NPRM is the most concrete evidence that FDA is moving forward with this plan. See , e.g. , ACLA White Paper on LDTs here. Javitt & McKenzie E.

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ISPE

JULY 5, 2023

7 A critical feature of the ETP is representation from all relevant FDA quality assessment and inspection programs, from early engagement with stakeholders through application submission and assessment. 13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter.

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Pharmaceutical Technology

MARCH 6, 2023

Currently, most drugs being investigated for their healthy aging or anti-aging properties are being repurposed from readily accessible FDA-approved drugs. Barzilai hopes that the well-established profile of the drug may allow the FDA to accept the trial more easily and then other aging-related studies can follow.

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Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. While in the US, the therapy is already being prescribed under an expanded access program , the FDA has requested additional data from a randomised, placebo-controlled trial before it will allow Egetis to schedule a PDUFA date.

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Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. In its 2022 annual report on generics, the US FDA stated it had approved 106 first generics, which it claimed would offer significant cost savings for patients. from 2001 to 2022.”

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Pharmaceutical Technology

APRIL 6, 2023

Verismo Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational new drug, SynKIR-110. Verismo Therapeutics CEO, DMD and co-founder Dr Bryan Kim said: “We are thrilled to receive Fast Track designation from the FDA.

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