Pharmaceutical Technology

SEPTEMBER 7, 2022

The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing decision. Pharmaceutical companies are increasingly integrating data-driven and software-centric medical adherence products to improve patient compliance. Patient adherence.

Pharmacy 130

Pharmacy Containment Manufacturing Compliance 130

Camargo

NOVEMBER 15, 2021

In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”. The guidance also contains some useful information, despite the limitations described above. FDA Publishes ICH Guidelines on Continuous Manufacturing.

Development 187

Development Manufacturing Production Packaging 187

XTalks

AUGUST 12, 2024

Despite the elimination of many lead-based products in the US, certain goods, especially those imported, may still contain lead. These may range from working with manufacturers to reduce lead levels to restricting the distribution of affected products in the US market.

Contamination 105

Contamination Compliance Regulation Production 105

Pharmaceutical Technology

SEPTEMBER 15, 2022

The list includes suppliers of a wide range of pharmaceutical packaging, containers and containment solutions, including plastic, glass and other customised packaging solutions, as well as labelling and printing solutions. Pharmaceutical packaging formats and materials. Trends in pharmaceutical contract packaging.

Packaging 100

Packaging Packaging Marketing Containment 100

Pharmaceutical Technology

SEPTEMBER 5, 2022

. · Programmes for treatment adherence and monitoring therapy compliance, and. The information in the download document is intended for executives, manufacturers, distributors, suppliers, technicians, research scientists, product development scientists, and other individuals involved in the pharmaceutical industry.

Production 147

Production Branding Scientist Compliance 147

XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Each module contains six standard sized containers, which measure 2.6

Vaccination 105

Vaccination Vaccine Production Manufacturing 105

Pharmaceutical Technology

SEPTEMBER 7, 2022

Pharmaceutical benefit managers and management companies serve as intermediaries between insurance companies, pharmacies, and drug manufacturers. The list includes companies that offer various benefit management services, including but not limited to: · Regulatory compliance. Health intelligence and analytics. Investigative services.

Pharmacy 100

Pharmacy Containment Manufacturing Compliance 100

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

Compliance 52

Compliance Clinical Development Development Clinical Trials 52

Pharma in Brief

APRIL 25, 2021

salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers to file an ANDS for an alternative form of a medicinal ingredient in comparison to the CRP. Proposed FDR Amendments Create Imbalance in Linkage Regime.

Regulation 98

Regulation Medicine Generic Drugs Containment 98

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Frozen” register.

Regulation 52

Regulation Compliance Medicine Manufacturing 52

XTalks

JULY 15, 2021

The test involves the use of testing strips that contain a glucose biosensor with electronic elements in the test’s transistor, like inks, that allow for mass printing of the test strips at low cost. The saliva test contains a glucose biosensor coated with the enzyme glucose oxidase and an electronic transistor. Biosensor Technology.

Development 98

Development Research Containment Manufacturing 98

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. extractables and leachables).

Packaging 98

Packaging Packaging Containment Production 98

FDA Law Blog

FEBRUARY 7, 2023

It is common to refer to FDA regulations as either pre-market, meaning they are applied before the device may be marketed, or post-market, meaning that compliance is generally required only after the device is brought to market, with some exceptions. Design controls (21 C.F.R.

Compliance 98

Compliance Marketing Regulation Development 98

XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Novo Nordisk, the pharmaceutical manufacturer of Ozempic and Wegovy, is actively addressing these supply challenges. The approved drugs contain the base form of semaglutide.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif.

Antibody 52

Antibody Manufacturing Production Sales 52

Roots Analysis

APRIL 15, 2024

Further, the manufacturing of biologics fill finish is a highly complex and cost-intensive process. Notable examples of fill finish manufacturing companies equipped with SA25 aseptic filling workstation include ( in alphabetical order ) Emergent Bioservices, PCI Pharma Services, Singota Solutions and WuXi Biologics.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

pharmaphorum

JUNE 8, 2022

Driving a Holistic Approach to Assurance of Product Sterility through Aseptic Manufacturing following QRM Principles. Conference Chairman: James Drinkwater, Head of Aseptic Processing Special Interest Group PHSS and Head of GMP Compliance, F Ziel GMBH. Delve into case studies of competence in global aseptic manufacturing.

Compliance 52

Compliance Contamination Manufacturing Production 52

FDA Law Blog

SEPTEMBER 26, 2022

Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 21 C.F.R. §

Production 40

Production Compliance Manufacturing Regulation 40

The Pharma Data

FEBRUARY 18, 2022

The company has introduced its approach to establishing scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution. The manufacturing solution consists of one drug substance and one formulation module, each called a BioNTainer.

Manufacturing 40

Manufacturing Vaccination Vaccine Production 40

FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

FDA Approval 72

FDA Approval Manufacturing Compliance Contamination 72

FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.

Production 115

Production Manufacturing Marketing Regulation 115

FDA Law Blog

FEBRUARY 9, 2024

is used in a clinical investigation of a drug or biologic under IND and the DHT meets the definition of a significant risk device a submission of an IDE to the FDA is required unless all the information required for the IDE is contained in the IND. smartphones and tablets) for remote data acquisition in a clinical investigation.

Compliance 105

Compliance Manufacturing Containment Regulation 105

FDA Law Blog

OCTOBER 5, 2022

The guidance also advised food manufacturers of FDA’s intent to exercise enforcement discretion for foods that are a good source of potassium, and vitamin D, as these two nutrients had been designated nutrients of public health concern in the 2016 final nutrition labeling regulation).

Containment 52

Containment Production Protein Regulation 52

FDA Law Blog

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package.

Drugs 52

Drugs Containment Packaging Packaging 52

FDA Law Blog

JULY 13, 2021

With the approach of the January 1, 2022 mandatory compliance deadline for the BE standard, manufacturers and importers of food and dietary supplements should work to develop strategies for compliance and evaluating each product’s bioengineered (BE) status if they have not already done so.

Compliance 52

Compliance Regulation Cosmetics Manufacturing 52

The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

XTalks

MAY 2, 2024

During a midday session, Anal Dave from Dessert Holdings and David Hatch, Vice President of Digital Solutions Marketing at Neogen , showcased their digital transformation strategies in environmental testing, enhancing detection and compliance.

Compliance 110

Compliance Regulation Production Containment 110

Roots Analysis

SEPTEMBER 20, 2023

The focus of stakeholders has now shifted to optimizing the cell therapy manufacturing process. It is worth noting that manufacturing process biologics and cell therapies is considerably complex when compared to small molecule drugs. The key steps involved in the supply chain of cell therapy manufacturing are presented below.

Manufacturing 40

Manufacturing Production Contamination Gene Therapy 40

FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. By Sophia R. Gaulkin & Riëtte van Laack — On May 16, the U.S.

Containment 45

Containment Contamination Manufacturing Compliance 45

FDA Law Blog

APRIL 8, 2024

This year’s report noted that CDER’s Drug Product Catalog contains over 140,000 entries, the same amount as OPQ listed in 2022. Readers also saw that that the Center’s manufacturing Site Catalog remains steady at more than 4,800 entries, the same number we found in the 2022 State of Pharmaceutical Quality report.

Manufacturing 59

Manufacturing Compliance Drugs Generic Drugs 59

The Pharma Data

JANUARY 14, 2021

(TSXV: THRM) (“Therma” or the “Company”), a progressive medical device technology company, is pleased to announce the appointment of Ian Levine to the advisory board to assist with future scaling for the manufacture of CoviSafe. as described in the news release.

Manufacturing 40

Manufacturing Sales Production Regulation 40

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

In-Vitro 81

In-Vitro Regulation Manufacturing Licensing 81

FDA Law Blog

SEPTEMBER 7, 2022

Number of Manufacturing Sites and Registered Products. The report states that for fiscal year 2021, there were 4,451 CDER drug manufacturing sites, which is a 3% increase over fiscal year 2018, the only comparison year provided. For fiscal year 2021, CDER oversaw 12,428 ANDAs, 3,537 NDAs and 315 BLAs. Import Alerts and Recalls.

Manufacturing 59

Manufacturing Production Containment Drugs 59

FDA Law Blog

FEBRUARY 15, 2023

The regulations contain many requirements that are over 30 years old. By amending and repealing certain parts of the regulation, FDA believes that compliance to standards adequately protect public health and provide a reasonable assurance of safety and effectiveness when appropriately used by trained personnel.

Radiology 52

Radiology Regulation Manufacturing Production 52

FDA Law Blog

MARCH 6, 2022

It is very common for a medical device manufacturing facility both to be certified as compliant with ISO 13485 and to have quality system procedures designed to comply with the FDA’s QSR. The gap between QSR requirements and ISO standards has created confusion for companies that focused compliance only on ISO certification.

Regulation 52

Regulation Compliance Manufacturing Packaging 52

Pharma in Brief

JUNE 9, 2021

The Federal Court has quashed a notice of compliance ( NOC ) issued to Médunik Canada ( Médunik ) for its amifampridine product, RUZURGI, over an issue concerning data protection for another amifampridine product. Catalyst ) filed an NDS for FIRDAPSE, which contains amifampridine. On November 16, 2019, Catalyst Pharmaceuticals, Inc.

Containment 52

Containment Production Compliance Drugs 52

pharmaphorum

MARCH 2, 2021

The use of RFID mobile track and trace devices provide detailed monitoring of vaccine shipments from the manufacturing plants to administration sites. The Internet of Things (IoT) devices, which are attached to each vaccine container during shipment, collect extensive location data and compile it into simplified reports and graphs.

Vaccination 119

Vaccination Vaccine Compliance Containment 119