FDA Law Blog

MARCH 2, 2022

By Riëtte van Laack — On February 18, 2022, the US Consumer Product Safety Commission’s (CPSC) Office of Compliance and Field Operations issued a guidance for household substances not intended for household use under the Poison Prevention Packaging Act (PPPA). No, that is not a typo.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Wholesale pharmaceutical companies also offer services such as end formulation contracts, which help pharmaceutical marketing companies and pharmacies locate manufacturing units across regions and coordinate negotiations when required. Discover the top pharmaceutical wholesalers. Selecting the best pharmaceutical wholesalers.

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Cloudbyz

MARCH 3, 2023

To address this challenge, mid-size CROs should invest in marketing and branding to increase their visibility and differentiate themselves from their competitors. Regulatory Compliance Compliance with regulatory requirements is critical for CROs. Regulatory Compliance Compliance with regulatory requirements is critical for CROs.

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FDA Law Blog

MARCH 21, 2024

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant. By John W.M.

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Pharmaceutical Technology

JUNE 14, 2023

Navigating the complexities of pharma and biotech packaging services can be difficult. With the growing number of complex therapies that require specialized packaging and handling requirements, selecting the right contract packaging organization (CPO) involves evaluating what services and additional benefits they can bring to your business.

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pharmaphorum

OCTOBER 12, 2022

Primary Packaging Development. Benefits of Attending: Engage with industry representatives on the latest trends within the pre-filled syringe and injectable device market. Delve into the considerations for material components for the development of primary packaging. Michael Becker, Packaging Engineer, Boehringer Ingelheim.

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Cloudbyz

JUNE 21, 2023

Utilize SDTM Conversion Tools: To convert the extracted data into SDTM format, employ SDTM conversion tools or software packages available in the market. Employ CDISC’s validation tools, such as OpenCDISC Validator or Pinnacle 21 Enterprise, to verify compliance with CDISC SDTM rules and guidelines.

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FDA Law Blog

OCTOBER 31, 2021

Under SB 343, a product or packaging is not recyclable in California if: It includes components, inks, dyes, adhesives, or labels that prevent its recyclability; It contains intentionally added chemicals identified pursuant to regulations implementing section 42370.2(g)(4) g)(4) of the California Public Resources Code; or.

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FDA Law Blog

NOVEMBER 16, 2021

Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics. In the pre-market area, Ms. In the post-market area, Ms. Prior to joining the Firm, Ms.

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Cloudbyz

MAY 24, 2023

This is where unified clinical trial management solutions come into the picture, enhancing efficiency, reducing time to market, and ensuring high-quality, scientifically validated consumer products. Time to Market: Consumer products operate in a highly competitive market where time is of the essence.

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Cloudbyz

MAY 11, 2023

Higher costs may be incurred for marketing, advertising, and investigator site payments for patient recruitment, as well as patient retention incentives and travel reimbursements. These costs may also involve audits, inspections, and any corrective actions required to address compliance issues.

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Pharma Marketing Network

MARCH 25, 2023

Companies can gather this information through market research and focus groups. This includes everything from the company’s website and social media presence to packaging and advertising. The industry is highly regulated, and companies must adhere to strict guidelines regarding the marketing and promotion of their products.

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pharmaphorum

MAY 27, 2022

The possibilities are endless, and in the context of trial participation and access to medicine technologies could assist: Reduced assessment times and hence increased patient compliance. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines.

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pharmaphorum

SEPTEMBER 15, 2022

It had been held up in the US by compliance issues that forced Mallinckrodt to change its packaging and labelling manufacturing facility and resulted in the FDA rejecting its application in February.

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The Pharma Data

MAY 26, 2023

The 6,000-square-meter Shiga site opened in October 2021 to support customers both locally and globally, providing flexible clinical supply solutions, including primary packaging, Catalent’s FastChain ® demand-led supply, white glove handling and logistics. With sites in the U.S.,

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pharmaphorum

OCTOBER 27, 2022

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. Therefore, companies are encouraged to establish a methodology for calculating fair market value rates.

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XTalks

JULY 5, 2022

A corporate compliance training program is a part of many onboarding programs to ensure employees are up to date with the latest rules and regulations they must adhere to while working for the company. Novartis trains and guides associates with a structured program consisting of ethics, risk and compliance.

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Roots Analysis

FEBRUARY 1, 2024

Further, the cold chain storage process involves the cold chain storage, cold chain transportation, and monitoring temperature controlled packaging products. Therefore, the pharmaceutical, biotech, food and chemical industries usually rely on cold chain packaging for the transportation of their products.

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Roots Analysis

APRIL 15, 2024

Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.

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pharmaphorum

JULY 13, 2021

Chief Executive Richard Adams says the creation of the new team reflects the company’s desire to improve the hands-on advice and assistance it can offer to its customers in an increasingly complex and fast-changing market and regulatory environment.

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Cloudbyz

OCTOBER 19, 2023

The pharmaceutical industry plays a critical role in improving healthcare by developing and bringing new medicines to market. Regulatory Compliance: Streamlining processes aids in meeting stringent regulatory requirements and maintaining data integrity.

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Imperical Blog

NOVEMBER 28, 2023

Labels are a lively commercial niche, and the global market for pharmaceutical labels… The post Clinical Trial Labeling: Don’t Get Stuck appeared first on Imperial Clinical Research Services Blog. Discover how Imperial CRS helped a client overcome some of the complexities of this critical clinical trial component.

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Advarra

JUNE 6, 2022

Receiving market launch approval requires completing the preparation for a pre-approval inspection (PAI) and transferring the production process into the area which will produce for market supply. This area needs to operate under full cGMP (manufacturing, quality control [QC], packaging, quality assurance [QA], and logistics).

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Clinical Trial Podcast

FEBRUARY 23, 2021

Rather than letting the clinical site continue enrollment, the PM decides to put the site enrollment on hold until the compliance issues are fully addressed and resolved. The PM anticipates the negative impact of compliance issues on the overall trial. A great project manager would drive to the airport and drop off that package.

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FDA Law Blog

NOVEMBER 22, 2022

Food and Drug Administration (FDA), requested withdrawal and destruction of all romaine lettuce on the market because the agency was unable at the time to tie the outbreak to a specific grower or region. Two days before Thanksgiving the following year, the CDC warned U.S. coli contamination. Concurrently, the U.S. 7, 2022 at 1 p.m.

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FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

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The Pharma Data

MAY 14, 2021

I’ve set up a discounted package system of 6 bottles of GlucoFlow for you, for only 49 dollars a bottle, for a total of 294 bucks which is being offered TODAYâ?¦for Just click the yellow button below after choosing the best package for you, and you’ll end up on our secure checkout page. for as long as supplies last.

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Advarra

SEPTEMBER 23, 2022

Before the FDA permits a pharmaceutical drug product to be lawfully marketed, sponsors are required to submit information about the product’s safety and efficacy so the FDA can determine : . Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . 21 CFR 312.3(b)

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pharmaphorum

JUNE 1, 2021

Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain. However, traceability and security measures focused on the packaging level may not be enough to protect patients. Reduce wastage.

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Drug Discovery World

JULY 11, 2022

David Lewandowski, Business Director of Cell & Gene Therapy at Azenta Life Sciences, explains how efficient sample management can help to work efficiently and bring therapies to market faster. The global cell and gene therapy (CGT) market reached a value of ~$4 billion in 2020 and is expected to grow to ~$34 billion by 2030 1.

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Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. The courts also had a busy year in 2021.

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FDA Law Blog

SEPTEMBER 26, 2022

211.166 – Stability Testing: Manufacturers may be able to leverage stability knowledge, data, or information for an already marketed combination product, for example, when the new combination product is a modification of an already marketed product and the modification does not impact the stability of the drug constituent part.

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pharmaphorum

NOVEMBER 24, 2022

And even once the facility is fit for purpose, specialised staff are required to maintain compliance with strict regulations. Namely, these include the backlogs and hassle associated with working with CDMOs or CMOs to develop new products and bring them to market. Enter cleanrooms-on-demand…. The future of COD.

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Pharmaceutical Technology

AUGUST 31, 2022

Forecasting, planning, procurement, stock levels, and marketing strategies are some of the areas that managers look at to overcome challenges with biopharmaceutical supply chains, and new innovations in the industry are revolutionising production methods. and Japanese Pharmacopoeia (JP).

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Pharma in Brief

DECEMBER 3, 2020

Health Canada has now begun the consultation process to transition drugs, vaccines and medical devices that were authorized under the interim orders to a more permanent market authorization under the relevant regulatory regime. require market authorization holders to meet post-marketing regulatory requirements; and.

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The Pharma Data

AUGUST 3, 2021

. – Second-quarter 2021 operating expenses increased 18 percent, driven primarily by higher research and development investments for late-stage assets, as well as higher relative marketing and selling expenses due to pandemic-related spending reductions in 2020. – Second-quarter 2021 earnings per share (EPS) decreased to $1.53

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Cloudbyz

JANUARY 13, 2021

Package Installation. Package Installation - Sandbox. A Product marketer, Entrepreneur and SAAS enthusiast. Package Installation. Package Installation - Sandbox. Compliance. Newsletter. Online Store. Pharma Tech Outlook. Phone Call. Public Relations. RainmakerKing. Sales Email Alias. Salesforce. Trade Show.

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