BioPharm

OCTOBER 24, 2023

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

Vaccines 52

Vaccines Documentation FDA 52

pharmaphorum

JUNE 29, 2022

Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). They are however both based on the original BA.1 1 will be “already somewhat outdated.”

Vaccines 52

Vaccines FDA Immunization Documentation 52

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

Documentation 52

Documentation FDA Communication Packaging 52

pharmaphorum

JANUARY 29, 2021

The EMA has approved AstraZeneca’s COVID-19 vaccine for use in the EU in all adults aged over 18, despite assertions in Germany this week that it shouldn’t be used in elderly people. That’s in line with the conclusions of the MHRA, which approved the vaccine at the end of last year. Janssen shot 66% effective.

Vaccines 64

Vaccines Documentation FDA 64

STAT

JUNE 9, 2023

At the meeting, the FDA is asking six independent experts to review a subsequent and larger Phase 3 clinical trial and vote on whether the results confirm Leqembi’s benefit. In documents released this week, FDA reviewers appeared receptive to granting full approval to Leqembi. Track the meeting here and here.

FDA 98

FDA Documentation Vaccines 98

STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. As of 2019, about 1.9 million people have type 1 diabetes in the U.S.,

FDA 98

FDA Documentation Compounding Pharmaceutical Companies 98

pharmaphorum

JULY 28, 2022

That means maintaining regulatory readiness – because having cGMP compliance problems with the FDA can significantly exacerbate the problem. The extraordinary scenario of producing vaccines for a global pandemic led to a well-documented shortage of vials, stoppers, and syringes, and finding a solution is no easy task.

FDA 111

FDA Documentation Compounding Dosage 111

The FDA Law Blog

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

FDA 108

FDA Documentation Vaccines 108

Viseven

DECEMBER 4, 2024

It also requires documenting the entire process, from raw material sourcing to product launch. It ensures compliance The Food and Drug Administration (FDA) in the U.S. This type of validation is particularly useful for fast product launches (think the COVID-19 vaccine) when there is no time for prospective validation.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 52

ISPE

AUGUST 30, 2022

Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). A formal change control system under the company’s pharmaceutical quality system (PQS) is required to evaluate all raw material changes, with established procedures for identification, documentation, review, and approval.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

OCTOBER 28, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Dr Gouws added that WHO was the only regulatory authority to have performed inspections of Chinese manufacturers of Covid-19 vaccines during the pandemic.

FDA 97

FDA Vaccines Documentation Dosage 97

The Checkup by Singlecare

MAY 24, 2024

Food and Drug Administration ( FDA ) has not approved the drug for use in companion animals. Azithromycin ( brand name Zithromax ) is a commonly used antibiotic that treats a broad spectrum of bacterial infections in cats, including skin infections, upper respiratory tract infections , pneumonia, bronchitis, and blood infections.

Immunization 95

Immunization Dosage Adverse Reactions Compounding Pharmacies 95

Digital Pharmacist

NOVEMBER 21, 2022

Food and Drug Administration (FDA) announced its approval of the Boostrix vaccine, commonly known as Tdap (combination of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis) for immunization administration during the third trimester of pregnancy to prevent pertussis in infants younger than two months of age.

Communication 98

Communication Documentation Immunization Vaccines 98

STAT

JANUARY 23, 2023

Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted by the FDA on Monday. Read the rest…

FDA 137

FDA Documentation Vaccines 137

pharmaphorum

APRIL 16, 2021

Even with the vaccine roll-out, further waves of COVID infection and lockdowns mean these vital drivers of launch performance remain impacted in 2021, and even beyond. Approval by regulators such as the FDA or EMA, as reported by the regulators themselves. We measured the pandemic impact on the launch of NAS at four levels.

Pharmaceutical Companies 95

Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 95

pharmaphorum

AUGUST 16, 2021

Nearly every element of the clinical trial design, data collection, analysis and approvals has been shortened and this helped ensure the swift rollout of safe and effective vaccines.”. Thankfully, paper-based studies are becoming a thing of the past, but spreadsheets and Word documents are still commonly used to design and build trials.

Documentation 98

Documentation Vaccines Packaging Pharmaceutical Companies 98

ISPE

OCTOBER 27, 2022

You will get answers to the following questions: How were the fill-finish processes for the SARS CoV-2 vaccines developed and qualified, and how did the manufacturers manage to provide vaccine doses in such large quantities in such a short time? SARS CoV-2 vaccines have been formulated in lipid nanoparticles.

Dosage 98

Dosage Vaccines FDA Documentation 98

European Pharmaceutical Review

JANUARY 16, 2023

He warned, “Implementation of a CCS will require more than writing documents.”. This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry.

Vaccines 128

Vaccines FDA Research Laboratories Documentation 128

pharmaphorum

JANUARY 18, 2022

The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience.

Packaging 52

Packaging FDA Documentation Vaccines 52

The FDA Law Blog

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. For post-approval pregnancy studies, it most certainly does.

FDA 59

FDA Documentation Vaccines 59

ISPE

OCTOBER 26, 2022

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , Complete Data Gathering.

Vaccines 97

Vaccines Compounding Documentation FDA 97

European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

Packaging 105

Packaging Vaccines Documentation FDA 105

ISPE

NOVEMBER 21, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Dr Gouws added that WHO was the only regulatory authority to have performed inspections of Chinese manufacturers of Covid-19 vaccines during the pandemic.

FDA 52

FDA Vaccines Documentation Dosage 52

The Checkup by Singlecare

NOVEMBER 5, 2024

It works best when administered before the cat is exposed to a reaction-inducing event like a vaccine shot. Hydroxyzine is not a common cat drug and has not been approved by the FDA for use in animals. Hydroxyzine is FDA-approved for use as a sedative in people. It is safe for cats but is less effective in cats than people.

Dosage 52

Dosage Vaccines Documentation FDA 52

ISPE

SEPTEMBER 11, 2023

Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” www.fiercepharma.com/manufacturing/sanofi-pumps-554m-into-new-vaccine-manufacturing-facility-eastern-france 41 Boccard. New Project: Evolutive Vaccines Facility for Sanofi.” www.boccard.com/evolutive-vaccines-facility-for-sanofi/ 42 Amgen.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

The FDA Law Blog

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. Remarkably, manufacturers may not dispute a CMS notification.

Vaccines 59

Vaccines Packaging FDA Documentation 59

pharmaphorum

DECEMBER 16, 2020

Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%. Both vaccines will be provided free of charge to recipients. The overall 94.5%

FDA 98

FDA Vaccines Documentation 98

ISPE

SEPTEMBER 8, 2023

Attendees were invited to submit questions to the FDA representatives. A highlight of the session was the mutual praise from industry and regulators on how well the two parties worked together during the pandemic to bring vaccines and drugs to the patients in record time. How will the FDA use Annex 1 in its final version?

FDA 52

FDA Vaccines Documentation 52

pharmaphorum

JANUARY 9, 2023

1 Kenya, for example, entered the pandemic with no human vaccines manufacturing facility and established the BioVax institute for local vaccine manufacture with a major plant investment starting in 2023. For pharma, the impact in critical areas such as the performance of newly marketed innovation has already been documented.

Vaccines 98

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 98

Pharmaceutical Technology

OCTOBER 28, 2022

QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). For example, the Covid-19 pandemic brought messenger ribonucleic acid (mRNA) vaccines into international prominence.

Vaccines 52

Vaccines Documentation FDA 52

BioPharm

MAY 18, 2023

The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.

Documentation 40

Documentation FDA Vaccines 40

pharmaphorum

FEBRUARY 25, 2021

Johnson & Johnson’s one-shot coronavirus vaccine is due to be reviewed by an FDA advisory committee on Friday, and according to the regulator meets the requirements for emergency use authorisation. According to the document, clinical trials filed to support the EUA show that Ad26.COV2.S S (JNJ-78436735) was 66.9%

FDA 59

FDA Vaccines Documentation 59

The Checkup by Singlecare

OCTOBER 17, 2023

Although this infection has been documented with almost all antibiotics, the most frequent offenders include clindamycin , ampicillin, amoxicillin, and cephalosporins. Certain vaccines interact with clindamycin , which can cause a diminished vaccine effect. Antibiotics can increase the risk of an infection called C.

Vaccines 52

Vaccines Documentation FDA Dosage 52

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.

Communication 98

Communication FDA Documentation Vaccines 98

Pharmaceutical Technology

NOVEMBER 15, 2022

Paxlovid first hit the shelves in the US last December after the Food and Drug Administration (FDA) granted the treatment an emergency use authorisation (EUA). Within Pfizer’s Covid-19 pipeline, Pfizer and BioNtech’s vaccine Comirnaty is also being used to fight the pandemic. 7)) and the other one in common between the BA.4

Vaccines 64

Vaccines Documentation FDA 64

pharmaphorum

DECEMBER 18, 2020

The FDA is looking to quickly approve Moderna’s COVID-19 vaccine after it was unanimously backed by a panel of experts. Pfizer’s vaccine was approved within a day of a positive vote from the Vaccines and Related Biological Products Advisory Committee.

FDA 64

FDA Vaccines Documentation 64

European Pharmaceutical Review

JULY 7, 2022

However, she notes that useful information for assessing risks in your facility and preparing for upcoming inspections can be gleaned from other’s warning letters and regulatory inspection observation reports, such as FDA 483.

Documentation 98

Documentation Vaccines FDA 98