A new technology offers treatment for HIV infection through a single injection - World Pharma News

According to the article:

"Currently, the researchers explain, there is no genetic treatment for AIDS, so the research opportunities are vast. Dr. Barzel concludes: "We developed an innovative treatment that may defeat the virus with a onetime injection, with the potential of bringing about tremendous improvement in the patients' condition. When the engineered B cells encounter the virus, the virus stimulates and encourages them to divide, so we are utilizing the very cause of the disease to combat it. Furthermore, if the virus changes, the B cells will also change accordingly in order to combat it, so we have created the first medication ever that can evolve in the body and defeat viruses in the 'arms race'.

Based on this study we can expect that over the coming years we will be able to produce in this way a medication for AIDS, for additional infectious diseases and for certain types of cancer caused by a virus, such as cervical cancer, head and neck cancer and more."

Read the full source article: A new technology offers treatment for HIV infection through a single injection - World Pharma News

Exploring better options for ACL repairs – MassDevice

Updated September 22, 2016

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NEW ACL SURGERY COULD CUT REHAB AND RECOVERY TIME IN HALF - An engineer-turned-doctor says clinical studies show real promise

- -  original post follows below  - -

Read more, and watch the animation: Exploring better options for ACL repairs – MassDevice:

"An anterior cruciate ligament (ACL) tear can be a devastating sports injury. Every year, 400,000 people, many of them teen and young adult athletes, sustain ACL injuries or tears. Martha Murray, MD, an orthopedic surgeon at Boston Children’s Hospital, worked with a team of colleagues to create a new procedure known as bridge-enhanced ACL repair (BEAR) that encourages natural healing."

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FDA approves 3-D printing for pills - 10 News

• People also search 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
  

Updated April 12, 2021

The original link broke.

Here's how to read about the same piece of news:

Printing Pills: FDA Approves First 3-D Printed Drug - SITNBoston Blog

---  the original post follows below  ---

Read the full article:  FDA approves 3-D printing for pills -  10 News: Tampa Bay Sarasota:

"The FDA has given approval to a new kind of pill – the first medicine made with a 3-D printer.

The drug is an anti-epileptic drug called Spritam. It’s the same drug as the widely prescribed Levetiracetam or Keppra."

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GMP Training Suggestions for 2014 - cGMP Essentials Course

 

483 Observation Gotchas!   1. There is no documented training in CGMPs. 2. CGMP training has not been conducted for over three years. 3. Firm lacks qualified CGMP trainers.      Planning for Training 2014!  2014 is just around the corner!  Do you need to get CGMP and related training completed and do not have the staff, or Are you and your staff already overloaded, or Do you just need a new and exciting approach to CGMP training? If you answered "Yes" to one or more of these questions, then take a look at our CGMP Essentials course. Learn More About the SkillsPlus CGMP Essentials course   Featured Course CGMP Essentials: This course can be structured with more than two dozen different training activities designed to reinforce learning and keep employees engaged. Prior students have high praise. One manager said, "I never knew CGMP training could be so much fun." One former FDA Inspector reported, "I actually learned something."   Topics addressed in this very popular course: 1. Heard on the Street 2. Review of 21 CFR 211 Subparts 3. Essential Quality System Tools 4. Consequences for non-compliance, and more!   If your firm needs a fresh new look at CGMP training, then you need to look into our CGMP Essentials course!   Examine The CGMP Essentials Course Outline   Allan Dewes, President.   About Your Instructor Allan Dewes   Allan Dewes has been training employees for over 40 years, with 30 years in the pharmaceutical industry. Allan understands CGMP regulations, the FDA expectations, and how to make training fun to maximize retention.   Email today to request a quotation

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The Exemptee Institute
The Designated Representative Institute

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Dietary Supplement Label Database (DSLD) - New from the NIH & NLM

Dietary Supplement Label Database (DSLD):

"The Dietary Supplement Label Database (DSLD) is a joint project of the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) and National Library of Medicine (NLM). The DSLD contains the full label contents from a sample of dietary supplement products marketed in the U.S."

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New Recommendations - Child Food Allergy Prevention

A committee from the American Academy of Asthma, Allergy, and Immunology (AAAAI) published new recommendations for parents aimed at helping prevent food allergies in young children.

Primary Prevention of Allergic Disease Through Nutritional Interventions. The Journal of Allergy and Clinical Immunology: In Practice. Volume 1, Issue 1 , Pages 29-36, January 2013

The journal article above, is pretty detailed and isn't a casual quick read.  The following might be a better quick introductory article:

• New Thinking On Preventing Food Allergies (Parade Magazine)

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It's Here! 2012 FDA Orange Book!

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

It finally arrived!

The FDA Orange Book for 2012 (32nd Edition)  has just been posted. It's current through Dec 31, 2011.

It's also posted in this location:
FDA - Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations: Publications

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Related articles

• Electronic Orange Book Online - It'll be a wait for the 2012 version (drughealth.blogspot.com)

New FDA Guidance - Physical-Chemical Identifiers for Anticounterfeiting

This just recently published by the FDA:

FDA Guidances (Drugs); Newly Added Guidance Documents:

Chemistry, Manufacturing, and Controls (CMC): Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 74KB - Final Guidance 10/11/11)

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Related articles

• Seven Strategies for Avoiding a 483 (drughealth.blogspot.com)
• Surviving FDA Enforcement Actions - Free Tips (drughealth.blogspot.com)
• Make GMP Training Effective - free tips (drughealth.blogspot.com)

CDC Updates To Sexually Transmitted Disease Treatment - Podcast and more

Image via Wikipedia

Updated August 25, 2021

The original links broke.

You can still read about this topic here:

CDC Updates To Sexually Transmitted Diseases - STI Treatment Guidelines

---  the original post follows below  ---

The CDC (Centers for Disease Control and Prevention) updated their guidelines for the treatment of persons who have or are at risk for sexually transmitted diseases (STDs).

For more information, including podcast:   The CDC's 2010 STD Treatment Guidelines website

Read the CDC 2010 STD Treatment Guidelines published in the MMWR (pdf)

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Brand New! FDA 2013 Orange Book 33rd Edition (pdf)

Updated March 3, 2020:

It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

New! - The 2010 FDA Approved Drug Products with Therapeutic Equivalence Evaluations 30th Edition (also known as the Orange Book).

Complete! - This FDA Orange Book 30th Edition is current through December 31, 2009.

Learn more about the Orange Book on the FDA website - Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).

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FDA New Guidance on PET Drugs GMPs

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

Updated June 24, 2024

The original link broke.

You can still read about the same topic here:

Guidance - PET Drugs — Current Good Manufacturing Practice (CGMP)  - FDA.gov

---  the original post follows below  ---

This FDA guidance, Guidance - PET Drugs — Current Good Manufacturing Practice (CGMP), is intended to help positron emission tomography (PET) drug producers better understand FDA’s thinking concerning compliance with the current good manufacturing practice (CGMP) regulations. The guidance addresses resources, procedures, and documentation for all PET drug production facilities, academic and commercial. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements.

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Flu.gov Updated by HHS - New Resources Added

The government's Department of Health and Human Services (HHS) unveiled several new resources on the federal government's one-stop resource for flu information -- https://www.cdc.gov/flu/. Some of the new items include:

• A self-evaluation guide
• A myth and facts section

Stay well!

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Free FDA IND Education For Small Business on Oct 15 2009

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Small Business Assistance, is announcing a public workshop on the Investigational New Drug Process, CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process.

• Agenda (PDF - 64KB)
• Registration form (PDF - 20KB)

Date: October 15, 2009 Time: 8:00 a.m. - 5:00 p.m.

Send the registration form to CDERSmallBusiness@fda.hhs.gov. For more information contact Ron Wilson at 301-796-3177 or Brenda Stodart at 301-796-3102. There is no registration fee Space is limited to 225 participants. The FDA appreciates advance notice of cancellations or replacements. Registration on the day of the event may be possible on a space availability basis. 

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New Guidelines Released for HIV Opportunistic Infections

The first complete update in five years of the U.S. guidelines for preventing and treating HIV-associated opportunistic infections has been released by the National Institutes of Health (NIH) and the Centers for Disease Control (CDC) and Prevention in cooperation with the HIV Medicine Association of the Infectious Diseases Society of America (IDSA). The new Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents apply state-of-the-art science and medicine to 29 infectious diseases of concern. More than 140 medical experts contributed their knowledge to this edition of the guidelines, released on April 10. These new guidelines can be viewed in either html or pdf formats: Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents (html) or Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents (pdf) 

Related Posts: CDC Adopts 2 New HIV Intervention Approaches HIV Pre Exposure Prophylaxis - Very Sharp Two Edged Sword HHS Updates HIV Treatment Guidelines (free pdf) 

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FDA - New CDRH Event Problem Codes

The FDA just published "CDRH Event Problem Codes. This CDRH website (with enhanced device and patient problem codes) provides you a PREVIEW to the updates that will be going live July 1, 2009. The FDA provides this information in advance to help you familiarize yourselves with Event Problem Code updates BEFORE the new codes ‘go live’ and are accepted in MAUDE. It's important to note that on July 1, 2009 - CDRH will begin accepting the updated codes. DO NOT submit these updated codes prior to that time because they will be rejected. Until that time FDA says to continue to use the current Event Problem Codes. April 2, 2010 is the target date to reject all inactivated and retired codes specified in this FDA update. The CDRH Event Problem Code initiative results in part, with updates to codes to reduce manufacturer reporting burden, improve adverse event report quality, and improve FDA’s ability to respond to device-related adverse events. 

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FDA Orange Book Online - Brand New Edition

• FDA GMP QSR cGMP Training - popular online training classes

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

- - - original post below - - -

You've been waiting for this. A brand new 29th edition, the 2009 FDA Orange Book Online. The products in this FDA Orange Book have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This volume, the 29th edition, is current through December 31, 2008.

According to the FDA, "This publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal® Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital Tablets]) are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the List contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act."

Related Posts:
Easy FDA Orange Book Search Widget
About The FDA Orange Book - Slide Deck (free)
FDA Orange Book - Online

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ASQ Announces Certification Exam For GMP Professionals

Updated May 24, 2016 - Old links just don't age well. I've made some edits.

PharmTech reports, New GMP Professional Exam Offered. It's great to see the bar getting raised with the proliferation of GMP certifications. It's nice to see the American Society for Quality (ASQ) jump into the fray by offering a certification exam based on their understanding of the body of knowledge (BOK) deemed necessary for GMP pros.

There are various degrees of rigor in GMP certifications being offered out there. Where do you think this will fit into the certification scene?

For more information:
ASQ Training & Certification
ASQ - The Value of an ASQ Certification

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New AHRQ Website On Emerging Issues In Medical Therapeutics

Updated January 30, 2021

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HCA data consortium with AHRQ and others seeks to speed COVID-19 research (HealthcareITnews) - Johns Hopkins, Duke, Meharry Medical College, Harvard Pilgrim and others will gain access to HCA's data registry to help boost patient outcomes and improve public health.

- - -  original post follows below  - - -

The Agency for Healthcare Research and Quality (AHRQ) announced a new educational website that offers expert perspectives, advice and guidance on drugs, biological products and medical devices from the AHRQ's Centers for Education and Research on Therapeutics (CERTs), a federally sponsored network of more than a dozen leading research centers nationwide. The new website, Clinician-Consumer Health Advisory Information Network (CHAIN) links clinicians and consumers with therapeutics information to assist in clinical practice and health care decisionmaking in areas where evidence is undergoing significant and rapid changes. This site will be of interest to manufacturers because of the touchpoints with clinicians, consumers, drugs, biologics, and medical devices, and CERT consultation and collaboration with the FDA. What do you think about the new site? Is it useful for your purposes? 

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Did You Pick One Of These Top 2009 New Year Resolutions?

Updated September 26, 2024

The original links broke.

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10 Tips to Treat and Prevent A Holiday Hangover - USA Today

---  the original post follows below  ---

Happy New Year!

Need a cure for a hangover? If so, then head over to 10 Tips to Treat and Prevent A Holiday Hangover.

If you chose a new year resolution for 2009, was it one of the following, reported by FranklinCovey Products' Fourth Annual New Year's Resolutions ... ? If you did choose one, I hope you picked a health-related resolution. In a nutshell, they're . . .

1. Get out of debt or save money
2. Lose weight
3. Develop a healthy habit (e.g. healthy eating, exercise)
4. Get organized
5. Spend more time with family and friends
6. Develop a new skill or talent
7. Work less, play more
8. Other
9. Break an unhealthy habit (e.g. smoking, alcohol, overeating)
10. Change employment

The real question is, are you going to keep your new year resolution? Live long and prosper in 2009!

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New Medicare Plan Search Tool - Joppel

Updated March 24, 2024

The original link broke.

You might also find this useful:

Explore your Medicare coverage options - Medicare.gov

---  the original link follows below  ---

Choosing the right plan can be very challenging. Try this newly released tool by Joppel. It's a free tool designed to search Medicare Advantage, Medicare Prescription Drug (Part D) and Medicare Supplement (Medigap) health plans simultaneously from all insurance carriers to match consumers to the plan that fits their coverage needs. It can be so confusing out there, so having access to free tools like this is really wonderful.

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