Trump, at Biopharma Meeting, Pledges to 'Streamline' FDA, Cut Regulations but Wants Lower Prices - TheStreet

Read more: Trump, at Biopharma Meeting, Pledges to 'Streamline' FDA, Cut Regulations but Wants Lower Prices - TheStreet:

"Biotech and drugs stocks are soaring Tuesday after President Donald Trump, meeting with CEOs of the biotech and pharma industries, promised to "streamline the FDA" and cut regulations so that new products can be brought to the market faster and cheaper."

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FDA Focusing On Food & Drug Manufacturing GMP Compliance

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Updated December 9, 2021

Links in the original post broke.

You might also like:

Current Good Manufacturing Practice (CGMP) Regulations - FDA.gov

Compliance & Enforcement (Food) - FDA.gov

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FDA is focusing on cGMP compliance by food and drug manufacturers.

FDA investigative chief eyes manufacturing practices:

"John Roth, director of the FDA's Office of Criminal Investigations, said officials are seeking to ensure that companies are appropriately balancing their profit motives with the need to manufacture food and drugs responsibly.

The meningitis outbreak and other recent cases have spurred the agency to take a closer look at this balance, Roth told lawyers at an American Bar Association-sponsored conference in Las Vegas focused on white-collar crime.

"We wonder exactly if this is a systemic problem, if it requires a broader response by the FDA or is it an anomaly," Roth said in a panel discussion Friday. "We're going to be taking a look at that and hopefully we'll launch in a thoughtful way.""

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You might also be interested in:
On the FDA website - FD&C Act Chapter III: Prohibited Acts and Penalties

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The Exemptee Institute
The Designated Representative Institute

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CMS Issues Sunshine Rule - Applies to Drug and Device Manufacturers

CMS Issues Sunshine Rule:

"The rule, a provision of the Affordable Care Act known as the Physician Payments Sunshine Act, "finalizes the provisions that require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children's Health Insurance Program to report payments or other transfers of value they make to physicians and teaching hospitals to CMS," the statement explained. "CMS will post that data to a public website. The final rule also requires manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests.""

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Physician Payments Sunshine Act (the "rule") - the Federal Register pre-publication version
Physician Payments Sunshine Act (the "rule") - the official Federal Register published version

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The Exemptee Institute
The Designated Representative Institute

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Pharma Forecast 2020: Cold Comfort

This summary article calls out a sobering list of things that are likely to put a damper on the pharma industry.

Pharma Forecast 2020: Cold Comfort:

"Despite such a bleak forecast, the report predicts “a golden era of renewed productivity and prosperity.” It recommends that above all, corporations should focus on collaboration with other players and academia, offer real-time outcomes data to establish value of medicines, reinvigorate corporate ethics standards, and use new procedures and technologies to revolutionize R&D. The message can be further condensed to something along the lines of: “Trim the fat and get with the times.”"

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Make GMP Training Effective - free tips

• FDA GMP QSR cGMP Online Training - popular GMP online training classes offered by SkillsPlus International Inc.

Updated November 1, 2021

The original link broke.

You might also be interested in recommended FDA CGMP online training courses and programs by SkillsPlus International Inc.

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More food for your GMP training thoughts. Some free training tips.

Why GMP Training Does Seem To Work - SkillsPlus International Inc. Training Tips (pdf):  'via Blog this'

In a nutshell:

• You must address poorly designed or delivered training.
• It is essential that you align what's preached with what's practiced.
• The organization must support and encourage GMP compliance in everything that they do.

For more information:

SkillsPlus International Inc. - Compliance training experts. GMP, QSR, Designated Representative and Exemptees.

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Massive Glossary of Pharma Biotech Terms - Free

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• The best choice for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs.

The ISPE (International Society for Pharmaceutical Engineering) has a free Glossary of Pharmaceutical and Biotechnology Terminology.

ISPE Glossary of Pharmaceutical and Biotechnology Terminology

It's truly massive, and free!   When I clicked on English language or browsed "All", it resulted in over 7,000 terms.

You can:

• search by term or language
• browse the list alphabetically

About the ISPE Glossary

Pharma Mergers - 2009 review - 2010 predictions

• FDA GMP QSR cGMP Online Training - recommended GMP online training courses provided by SkillsPlus International Inc.

Continuing the thread of the pharma year in review, and what 2010 might look like. Here's a Motley Fool look at 2009 and 2010 from the perspective of pharmaceutical mergers and acquisitions, 2009: The Year Pharma Learned to Love Itself. In a nutshell:

1. 2009 ushered in a number of consolidations
2. Consolidations might not work well or scale well due to the challenges of integration
3. The author, Brian Orelli predicts for 2010, "While anything is possible, I wouldn't expect much more consolidation of major drugmakers."

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Biotechnology Trends 2010 - Free Report

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Here's the next installment of my hunt for 2010 trends, forecasts, and predictions. Pharma-Reports.com just announced the availability of its executive report, Biotechnology Trends 2010 (free). I've provided the link to the request form. The report examines the most significant trends in biotechnology and their impact on rising health care costs, the aging population, and an overall rise in the incidence of disease. The report also discusses scientific advancements in proteomics and biomarkers, molecular manufacturing, and the development of smart materials.

Previous Posts: Looking Ahead to Pharma 2010 - Through the IBM innovation lens GMP Training - The end is near - I mean 2009! IMS Predicts Pharma Growth in 2010 CDC - Brand New 2010 Yellow Book for Travelers - free - online 

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Free Intro To Biomedical Engineering (videos)

Updated August 26, 2024

The structure of the Academic Earth site has changed.

You can find many of the mentioned classes, through their search function.

Here's one search, using "biomedical engineering" to get you started:

https://academicearth.org/?s=biomedical+engineering

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This is a collection of free video lectures by Mark Saltzman of Yale, hosted on the Academic Earth website. He covers basic concepts of biomedical engineering and their connection with the spectrum of human activity. His lectures serve as an introduction to the fundamental science and engineering on which biomedical engineering is based. Case studies of drugs and medical products illustrate the product development-product testing cycle, patent protection, and FDA approval. It is designed for science and non-science majors. This should be of some interest to those in the biotech, drug, and medical device industries. Here's the list of his free video lectures: Lecture 1 - What Is Biomedical Engineering? Lecture 2 - What Is Biomedical Engineering? (cont) Lecture 3 - Genetic Engineering Lecture 4 - Genetic Engineering (cont) Lecture 5 - Cell Culture Engineering Lecture 6 - Cell Culture Engineering (cont) Lecture 7 - Cell Communication and Immunology Lecture 8 - Cell Communication and Immunology (cont) Lecture 9 - Biomolecular Engineering: Engineering of Immunity Lecture 10 - Biomolecular Engineering: Engineering of Immunity (cont) Lecture 11 - Biomolecular Engineering: General Concepts Lecture 12 - Biomolecular Engineering: General Concepts (cont) Lecture 13 - Cardiovascular Physiology Lecture 14 - Cardiovascular Physiology (cont) Lecture 15 - Cardiovascular Physiology (cont) Lecture 16 - Renal Physiology Lecture 17 - Renal Physiology (cont) Lecture 18 - Biomechanics and Orthopedics Lecture 19 - Biomechanics and Orthopedics (cont) Lecture 20 - Bioimaging Lecture 21 - Bioimaging (cont) Lecture 22 - Tissue Engineering Lecture 23 - Tissue Engineering (cont) Lecture 24 - Biomedical Engineers and Cancer Lecture 25 - Biomedical Engineers and Artificial Organs 

Related Posts: Structural Aspects of Biomaterials - More than 20 free video lectures 

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New FDA Genomics Position Announced

I'm glad to see this, as reported by Medscape Medical News, FDA Creates New Genomics Position. With burgeoning scientific advances in this area, it's great to see the FDA attempting to stay caught up with the rest of the industry sector. I remain hopeful of the FDA doing the right things, and am happy to see them being appropriately influenced, as evidenced by this quote . . . Dr. Torti said, "The FDA's emphasis on a coordinated genomics effort is the outcome of the June 2008 FDA Symposium and Retreat on Genomics, the recommendations of FDA's advisory Science Board, and our own internal planning."

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Think Like An FDA Inspector - Be Prepared

• FDA cGMP QSR GMP Training - respected online training courses by SkillsPlus Intl Inc.

Revised December 16, 2020

Yep, it's important to follow all the regulations. AND, it helps to understand how the FDA inspector will approach your company during an inspection. On the FDA website, several free documents are published as reference material for investigators and other FDA personnel. The documents don't bind the FDA and don't confer any rights, privileges, benefits or immunities for or on any person(s). Basically, they'll help you prepare and anticipate what to expect from an FDA inspector and inspection team. Just be forewarned, it also means that they don't have to follow the suggestions or recommendations mentioned in the inspection guides. Here's a listing of the major categories of inspection guides that are available . . .

"Guide to Inspections of:

• Biotechnology
• Computer Issues
• Devices
• Drugs
• Foods & Cosmetics
• Miscellaneous

Note: These documents are reference material for investigators and other FDA personnel. The documents do not bind FDA and do not confer any rights, privileges, benefits or immunities for or on any person(s). An alternative approach may be used if such an approach satisfies the applicable statutes, regulations or both."

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GMP News Sources - updated list for free

• Respected FDA cGMP online training programs and courses by SkillsPlus International Inc.

Updated March 22, 2022

This is a collection of health, drug, and GMP news and industry publications. Use this to update your knowledge of current events, or to work the latest information and knowledge into your upcoming classroom or training event. This list is provided to you for free.

Biospace Newsfeeds - Biotech and Pharmaceutical News
BioWorld Online - the worldwide biotechnology news and information source
European Compliance Academy Newsfeeds (2022)
FDA WebView - the internet's fastest FDA news center
GMP Trends - an online and printed GMP information source
Health, Drug, Prescription, GMP Supersite - reference additional news sources on the Blog List
Pharmaceutical Business Review - the latest news, comment, and industry information
Pharmaceutical Online - the online industry standard

You might also be interested in the Health & FDA-related news, that displays on this blog's Blog List (just scroll down the left sidebar of this blog).

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Job Opportunities in the GMP and Health Sector

• The best FDA cGMP online training courses and programs - Taught by SkillsPlus International Inc.

Updated March 4, 2022

As you can imagine, this 2008 posts just didn't age well.  Sorry.

You might also be interested in:

cGMP Jobs in the U.S. - LinkedIn

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Pursue this list of jobs, and job hunting resources. Plan your career in the health, drug, and regulated industries (e.g., GMP, drug manufacturing) or look for your next job, consulting engagement, or opportunity amongst these job hunting links. Getting one of these jobs can put you in a place to influence, guide, and support ethical research and manufacturing of medical devices and drugs. 

• Bio Jobs - blog of biopharmaceutical jobs, tools, many topics
• Careers with i3global - the company of specialists
• cGMP Job Listings - by job-hunt.org
• Executive Recruitment Services - by Med Exec Intl. Jobs in clinical research, QA, medical affairs, regulatory affairs
• GMP Consultancy Opportunities from MasterControl
• GMP Job Listings - by CareerBuilder
• GMP Job Listings - by CareerJet
• GMP Job Listings - by Juju 
• GMP Job Listings - by MySpace
• GMP Job Listings - by SimplyHired
• GXP Job Listings - by GXP Recruiters
• i3 Pharma Resourcing - pharmaceutical personnel placement
• RegulatoryOpenings.com - Regulatory, QA, Clinical, and Medical Writing openings & jobs

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GMP News Sources

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

Updated August 19, 2024:

This is a collection of health, drug, and GMP news and industry publications. Use this to update your knowledge of current events, or to work the latest information and knowledge into your upcoming classroom or training event. 

BioWorld Online - the worldwide biotechnology news and information source
FDA WebView - the internet's fastest FDA news center
Pharmaceutical Business Review - the latest news, comment, and industry information
Pharmaceutical Online - the online industry standard

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