Federal Register | FDA Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability

Federal Register | Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability:

"FDA is announcing the availability of a guidance for industry entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.” On July 9, 2012, FDASIA (Pub. L. 112-144) was signed into law. Section 707 of FDASIA adds 501(j) to the FD&C Act to make a drug adulterated that “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” As required by Section 707, FDA is issuing this guidance to define the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of Section 501(j) of the FD&C Act."

'via Blog this'

Read the FDA Final Guidance:
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (PDF - 106KB)

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Reports > FDA Strategic Priorities: 2014 - 2018 - FDA.gov

• FDA CGMP online training courses sold by SkillsPlus International Inc.

Read the full article: Reports > FDA Strategic Priorities: 2014 - 2018 - FDA.gov:

"This Strategic Priorities document articulates the goals and priorities that guide our Agency. It creates a framework that will allow us to integrate and achieve our five strategic priorities – regulatory science, globalization, safety and quality, smart regulation, and stewardship.

While the priorities are individually important, they are also interconnected and cannot be addressed in isolation. Thus, for example, regulatory science is at the core of everything FDA does and therefore it influences and in turn is affected by any actions taken involving the other priorities. The cross-cutting nature of this plan will help FDA achieve the greatest benefits.

This document also sets forth FDA’s core mission goals and objectives, such as improving and safeguarding access to – and making better informed decisions about – the products FDA regulates. It describes in detail key strategies to help the Agency fulfill its public health mission."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov

Read the full press release:  Press Announcements > The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov:

"To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.

The final guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” recommends that manufacturers consider cybersecurity risks as part of the design and development of a medical device, and submit documentation to the FDA about the risks identified and controls in place to mitigate those risks. The guidance also recommends that manufacturers submit their plans for providing patches and updates to operating systems and medical software."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Guidance Outlining Up to 10 Quality Metrics Expected by Year’s End: FDA Official | 2014-09-26 | FDANews

• FDA GMP Online Training - trusted FDA CGMP online training courses offered by SkillsPlus International Inc.

Guidance Outlining Up to 10 Quality Metrics Expected by Year’s End: FDA Official | 2014-09-26 | FDANews:

"The FDA is honing in on roughly eight to 10 quality metrics that the agency plans to collect from drugmakers starting in 2015, and expects to publish a guidance that names them by the end of the year."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

Foresight is 20/20: The Need For Pharmaceutical Companies to Implement Robust Anti-Corruption Programs - Pharmaceutical Compliance Monitor

Updated September 4, 2024

Unfortunately, the original link broke.

---  the original post follows below  ---

More insights in the full article: Foresight is 20/20: The Need For Pharmaceutical Companies to Implement Robust Anti-Corruption Programs - Pharmaceutical Compliance Monitor:

"In the wake of the recent FCPA enforcement activity, the government has signaled its renewed attention to pharmaceutical companies. It is therefore imperative that pharmaceutical companies doing business abroad assess their individual risks, develop compliance goals, and create and implement a comprehensive compliance program that evolves in conjunction their risk profile and ever-changing enforcement trends."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Poor Quality Drugs and Global Trade: A Pilot Study - NBER.org

Read the rest of the abstract: Poor Quality Drugs and Global Trade: A Pilot Study - NBER.org:

"Experts claim that some Indian drug manufacturers cut corners and make substandard drugs for markets with non-existent, under-developed or emerging regulatory oversight, notably Africa. This paper assesses the quality of 1470 antibiotic and tuberculosis drug samples that claim to be made in India and were sold in Africa, India, and five mid-income non-African countries. We find that 10.9% of those products fail a basic assessment of active pharmaceutical ingredients (API), and the majority of the failures are substandard (7%) as they contain some correct API but the amount of API is under-dosed. The distribution of these substandard products is not random: they are more likely to be found as unregistered products in Africa than in India or non-African countries."

'via Blog this'

Read the study paper:
Poor Quality Drugs and Global Trade: A Pilot Study (Roger Bate, Ginger Zhe Jin, Aparna Mathur, Amir Attaran). NBER Working Paper No. 20469. Issued in September 2014 (PDF)

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

FDA could be source of innovation, Hamburg says - Denver Business Journal

Read the full article: FDA could be source of innovation, Hamburg says - Denver Business Journal:

"The FDA, in the course of approving new drugs and devices and overseeing their safety and effectiveness, gains broad knowledge of what companies are doing, what researchers are discovering about disease and how that relates to medical outcomes.

Hamburg’s vision is for the FDA to use that position to help researchers and companies make more effective new treatments and prove new medical advances more quickly, she said.

“We have a lot more to offer than has historically been appreciated,” said Hamburg, U.S. Commissioner of Food and Drugs since 2009. “The regulator has a very different role than the innovator or the academic researcher, but we can be a very effective partner for both.”"

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

FDA - Biosimilars > Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations

• Buy now! FDA GMP online training courses provided by SkillsPlus International Inc.

Read the full announcement: Biosimilars > Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations - FDA.gov:

"The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.

Separate lists for those biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will be updated periodically."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Virulent Chinese Hacking Group Mows Through U.S. Medtech, Pharma - Washington Post

Updated February 26, 2021

Links in the original post broke.

People also ask about:

Virulent Chinese hacking group mows through U.S. health industries - SCNOW

- - -  original post follows below  - - -

Read the full article: Virulent Chinese Hacking Group Mows Through U.S. Medtech, Pharma - Washington Post Business Page, Business News:

"The breaches have forced companies to boost efforts to protect their computer banks. On average, health-care companies spent $2.2 million on information security in 2013, a more than 20 percent increase from the prior year, according to a PwC, CIO and CSO magazine survey.

“I recently met with three CEOs in health care and in most cases they had come to the conclusion that they definitely did under-invest,” said Mick Coady, a partner at PwC’s health information privacy & security group. “Health care is at least a decade, if not more, behind.”"

'via Blog this'

Return to SkillsPlus International Info Blog - Home

FedEx Faces Money-Laundering Charge in Revised Indictment - Bloomberg

Read the full article: FedEx Faces Money-Laundering Charge in Revised Indictment - Bloomberg:

"The allegations of a conspiracy to launder money were included in a revised indictment against the company filed today in federal court in San Francisco. FedEx and individuals who ran the illicit pharmacies “knowingly and intentionally” schemed to launder more than $630,000 in shipping payments that were derived from drug sales, federal prosecutors said in the indictment.

The government has said that FedEx and its co-conspirators could face a fine of twice the gains from the conduct, alleged to be at least $820 million."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around