Pharmaceutical Technology

JANUARY 31, 2023

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Moderna ’s investigational mRNA vaccine candidate, mRNA-1345, for respiratory syncytial virus (RSV) in adult patients. In August 2021, the US FDA granted Fast Track designation to mRNA-1345.

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Vaccines FDA Communication 72

Pharma Marketing Network

DECEMBER 31, 2024

Follow FDA guidelines on advertising to ensure your messaging is accurate and ethical. Develop blogs, white papers, and videos that educate and engage. Follow FDA guidelines, ensure accurate messaging, and work closely with legal and regulatory teams to review campaigns. Disclaimer: This content is not medical advice.

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FDA 52

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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Communication FDA 119

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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Communication FDA 111

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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FDA 75

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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Communication FDA 52

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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FDA Immunization 59

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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FDA Generic Medicine Communication 98

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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FDA Hospitals 59

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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FDA Process Improvement 59

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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FDA Communication 52

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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FDA Labelling Documentation Communication 52

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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Communication Labelling FDA 59

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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Communication FDA 64

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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FDA 52

Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

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Documentation FDA Hospitals Dosage 97

Pharmaceutical Technology

MARCH 20, 2023

The US Food and Drug Administration (FDA) granted Fast Track designation to ONC-392 as a monotherapy to treat immunotherapy-resistant non-small cell lung cancer (NSCLC). A randomised Phase III trial of ONC-392 as monotherapy is planned to commence this year.

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Compounding Communication FDA 98

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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FDA Labelling 59

Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

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Labelling Insurance Communication FDA 105

Pharmaceutical Technology

MARCH 1, 2023

Recently, the US Food and Drug Administration (FDA) granted emergency use authorisation (EUA) for Paxlovid, an inhibitor for the first protease of SARS-CoV-2 (Mpro). The licensed technology specifically includes small molecules found to be efficient PLpro inhibitors.

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Communication Immunization FDA 59

Pharmaceutical Technology

JANUARY 15, 2023

FDA expands approval labels. The FDA passed several positive supplementary approval decisions involving younger patients. Regulatory decisions by the US FDA from late November to mid-December for select therapies, and the CMOs contracted to manufacture them. Source: GlobalData Pharmaceutical Intelligence Center.

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Labelling Packaging FDA Communication 52

Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

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Communication Labelling Hospitals FDA 104

Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

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Labelling Insurance Communication FDA 98

Pharmaceutical Technology

MARCH 21, 2023

So far, the FDA has approved just one CBD product, a prescription drug designed to treat seizures associated with Lennox Gastaut syndrome (LGS) [i]. But according to GlobalData, medical cannabis research is set to escalate.

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Communication FDA 97

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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HIPAA Communication FDA 52

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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HIPAA Communication FDA 52

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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Documentation FDA Communication Labelling 98

Pharmaceutical Technology

FEBRUARY 28, 2023

The US Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) have accepted the investigational new drug (IND) application for a Phase I trial of YH008. With this agreement in place, we will work together to accelerate YH008’s entry into the market to benefit patients.”

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Immunization Communication FDA 52

Pharmaceutical Technology

FEBRUARY 6, 2023

The FDA approved both drugs in 2014. On February 2, the FDA cleared an Investigational New Drug Application for PLN-101095. The standard treatments for IPF include Esbriet ( pirfenidone ) which is marketed by Genentech, a part of Roche, and Boehringer Ingelheim’s Ofev ( nintedanib), which are used to slow disease progression.

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FDA Pharmaceutical Companies Pharmaceutical Companies Communication 59

Pharmaceutical Technology

FEBRUARY 23, 2023

Fraction absorbed is directly related to the solubility, dissolution, and permeability of a compound and is the amount of drug that enters the intestinal enterocyte in our gastrointestinal tract (FDA definition), whereas bioavailability (F) is the amount of drug in the systemic circulation able to have a therapeutic effect.

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Compounding Dosage Packaging Communication 98

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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FDA Communication Insurance 40

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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FDA Communication Insurance 40

Pharmaceutical Technology

NOVEMBER 30, 2022

In the first official regulatory guidance on this matter released in 2008, the Food and Drug Administration (FDA) established CCIT as a requirement, closely tying it to the concept of microbiological integrity. In the same year, the European Commission published guidance relating to the manufacture of sterile medicinal products.

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Packaging FDA Communication 52

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.

Documentation 52

Documentation Dosage Packaging Communication 52

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.

Documentation 52

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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FDA Hospitals Dosage Controlled Substances 59