Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies have also entered the social media marketing domain in compliance with governmental regulations to communicate directly with patients using covert persuasion methods such as collaboration with social media influencers. Discover the leading direct-to-consumer pharmaceutical marketing companies.

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Marketing Compliance Doctors Doctor 130

Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. The download contains detailed information on commercial pharmaceutical packaging contractors, and their product and service lines, alongside contact details to aid your hiring decision.

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Packaging Packaging Marketing Containment 130

Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen.

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Drugs Regulation FDA Approval Manufacturing 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. million).

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Drugs Containment Packaging Packaging 52

Worldwide Clinical Trials

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure. Here are a few of our lessons learned: 1.

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Clinical Trials Clinical Trials Pharmacy Trials 200

Pharmaceutical Technology

SEPTEMBER 7, 2022

Pharmaceutical benefit managers and management companies serve as intermediaries between insurance companies, pharmacies, and drug manufacturers. They bring together employers/plan sponsors, health insurers, plan members, drug wholesalers, pharmacies, and drug companies to facilitate better health outcomes at an affordable cost.

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Pharmacy Containment Manufacturing Compliance 130

FDA Law Blog

SEPTEMBER 26, 2022

requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices). 21 C.F.R. § Section 21 C.F.R Section 21 C.F.R

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Production Compliance Manufacturing Regulation 40

Drug Discovery World

AUGUST 9, 2023

Darren Mercer, Chief Executive of CSP, said: “We are thrilled to acquire AxeroVision, and in particular the pipeline product AXR-270 which contains a novel selective glucocorticoid receptor agonist formulated in a cutting-edge drug delivery system that overcomes the issues of poor compliance and inefficient delivery of conventional eye drops.”

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Drugs Drug Delivery Systems Drug Delivery Life Science 52

Roots Analysis

MAY 24, 2024

In the dynamic landscape of the healthcare sector, the evolution of drug delivery systems plays a significant role in transforming the management of chronic diseases. They are generally used in combination with primary containers, such as prefilled syringes and cartridges. These allow precise and consistent delivery of a fixed dosage.

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Drug Delivery Containment Contamination Production 40

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. In a display of the competition within the generic industry that keeps margins low , this total included 118 new drug applications and 956 generic drug applications.

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Manufacturing Compliance Generic Drugs Drugs 59

XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). As of May 2023, both Ozempic and Wegovy were on the FDA’s Drug Shortages list due to a global shortage of semaglutide. The approved drugs contain the base form of semaglutide.

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FDA Approval Containment Drugs Pharmacy 98

Pharmaceutical Technology

SEPTEMBER 5, 2022

. · Programmes for treatment adherence and monitoring therapy compliance, and. Documentation for a faster drug authorisation process. The document contains detailed information on the suppliers and their product offerings, alongside their contact details to aid your purchasing or hiring decision.

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Branding Production Scientist Compliance 147

pharmaphorum

NOVEMBER 17, 2021

SMi Group’s 14 th Annual Conference and Exhibition: Pre-Filled Syringes and Injectable Drug Devices 2022 – 12 th – 13 th January 2022. Sustainability for Drug Devices Focus Day – 14 th January 2022. The Future of Drug Delivery and Combination Product Device Design. London, UK www.pre-filled-syringes.com/Pharmaphorum.

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Drugs Drug Delivery Engineer Production 52

Drug Discovery World

JULY 31, 2023

Darren Mercer, Chief Executive of CSP, said: “We are thrilled to acquire AxeroVision, and in particular the pipeline product AXR-270 which contains a novel selective glucocorticoid receptor agonist formulated in a cutting-edge drug delivery system that overcomes the issues of poor compliance and inefficient delivery of conventional eye drops. “On

Drug Delivery Systems 52

Drug Delivery Systems Containment Drug Delivery Compliance 52

FDA Law Blog

DECEMBER 3, 2023

Conditions for Coverage after January 1, 2025: Any manufacturer that wishes to have its applicable drugs covered under Medicare Part D after January 1, 2025 (“participating manufacturers”) must execute a Discount Program agreement with CMS by March 1, 2024. Non-applicable drugs (e.g.,

Manufacturing 105

Manufacturing Drugs Compliance Pharmacy 105

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.

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Packaging Packaging Containment Production 98

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.

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Containment Contamination Compliance Manufacturing 45

Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Continued authorization for COVID-19 drugs.

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Regulation Drugs Vaccination Vaccine 52

Pharma in Brief

APRIL 25, 2021

As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g., Interested persons have 30 days to make representations concerning the Proposed PM(NOC) Amendments.

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Regulation Medicine Generic Drugs Containment 98

FDA Law Blog

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. Providers should be aware of the other drugs prescribed to their patients. 6, 2023 ( DOJ Press Release ). Complaint ¶ 60.

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Pharmacy Containment Drugs Compliance 139

XTalks

MAY 17, 2024

Eli Lilly announced it has reached a settlement with a medical spa selling counterfeit versions of the company’s blockbuster tirzepatide GLP-1 drugs Mounjaro and Zepbound. The spa can obtain and distribute compounded tirzepatide products on the condition that they are produced in compliance with US federal law.

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Sales FDA Approval Pharmacy Production 52

CTTI (Clinical Trials Transformation Initiative)

JANUARY 10, 2024

After the relevant themes were assessed, CTTI surveyed 92 individuals who represented 84 unique organizations and condensed this information into a report containing strategies and recommendations for improving registration and reporting.

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Clinical Trials Clinical Trials Trials Compliance 65

Pharma in Brief

SEPTEMBER 8, 2022

On August 17, 2022, the Federal Court dismissed applications for judicial review regarding the product-specificity requirements for addressing patents listed on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Background. mL strength pre-filled syringe). mL pre-filled syringe.

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Marketing Drugs Regulation Compliance 52

FDA Law Blog

FEBRUARY 9, 2024

The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices. g)), or simply used to collect data as part of a clinical investigation of a drug, biologic, or different medical device. investigational device as defined in 21 C.F.R. c) a submission of an IDE to the FDA is not required.

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Compliance Manufacturing Containment Regulation 105

Pharma in Brief

MAY 29, 2023

Background A CSP can extend, for up to two years, patent protection for a drug containing a new medicinal ingredient or a new combination of medicinal ingredients. However, an earlier, limited-purpose authorization generally should not prohibit a drug that later obtains an NOC from also obtaining a CSP.

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Regulation Sales Clinical Trials Clinical Trials 59

Delveinsight

JANUARY 22, 2021

The launch of a novel drug in the market is not less than a celebration in the pharmaceutical and healthcare market; however, it also brings the real challenge of sustenance in the market. Similar is the picture of the Thrombocytopenia Drugs Market. Drug-Induced Thrombocytopenia, Gian Paolo Visentin, Chao Yan Liu).

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Marketing Drugs Antibody Compliance 65

Intouch Solutions

APRIL 11, 2024

It has continually evolved, embracing new technologies and methodologies to improve drug discovery, development, and distribution. Pre-Clinical : Deeper comprehension of the impacts and outcomes associated with a particular drug. Compliance concerns have also been addressed, particularly concerning specific project areas.

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Compliance Marketing Drugs Pharma Companies 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.

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Compliance Regulation Production Containment 110

FDA Law Blog

JUNE 9, 2021

Koblitz — While typically, FDA is responsible for setting forth its own agenda and enforcing compliance with its own regulations, the Trump Administration’s HHS, on its way out the door in late 2020 , took the unusual steps of withdrawing an important FDA Compliance Policy Guide, “Marketed Unapproved Drugs – Compliance Policy Guide Sec.

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Compliance Drugs Production Marketing 52

Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. However, this needle system does not contain a proper locking system, therefore, increased the chances of leakage.

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Drug Delivery Contamination Drugs Production 40

XTalks

FEBRUARY 21, 2022

The BioNTainer is housed in shipping containers equipped with state-of-the-art technology for producing the mRNA vaccines from start to finish, except for the final fill-and-finish step that will be performed by local manufacturing partners. Each module contains six standard sized containers, which measure 2.6

Vaccination 105

Vaccination Vaccine Production Manufacturing 105

Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

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FDA Law Blog

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. That leaves 60% that manufacture at least one application product.

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Manufacturing Contamination Production Drugs 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.

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Compliance Cosmetics Regulation Manufacturing 52

Camargo

NOVEMBER 15, 2021

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). The guidance also contains some useful information, despite the limitations described above.

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Development Manufacturing Production Packaging 187

Pharmacy Checkers

FEBRUARY 28, 2020

The report is an audit of companies in the drug supply chain to test compliance with regulations called for by the Drug Supply Chain Security Act of 2013 (DSCSA). In short, as reported in STAT , OIG found that seven out of 44 drugs audited could not be traced back to the manufacturer in the manner required under the DSCSA.

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Pharmacy Drugs Sales Compliance 55

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. of the Food and Drug Regulations (the Data Protection Provisions ). Background.

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Containment Production Compliance Drugs 52