IATA Perishable Cargo Regulations

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The International Air Transport Association (IATA) represents some 230 airlines comprising 93% of scheduled international air traffic.

IATA publishes The Perishable Cargo Regulations Manual: THE standard for cargo handling (buy online)

According to IATA, The Perishable Cargo Regulations (PCR) manual is the leader in temperature control and cold chain management for goods from the health care and food sectors, including pharmaceutical products and non-hazardous biological materials and includes everything you need to properly prepare, package and handle time and temperature sensitive goods quickly and efficiently.

Additional IATA resources related to perishable cargo

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FDA Controversy - Regen Biologic's Menaflex Device

The FDA is reassessing the safety of a device (Regen Biologic's Menaflex Device) that it previously approved for patients. The FDA conducted a March 23, 2010: Orthopaedic and Rehabilitation Devices Panel Meeting. Although the panel expressed that they would have liked to have seen more data on the device, they largely backed it as a safe and effective therapy.

The larger looming issue now is whether this will become precendent setting and raise the prospect of FDA re-evaluating previously approved devices.

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FDA Proposes Electronic Safety Reporting

The FDA states in their news release, FDA Proposes Mandatory Electronic Safety Reporting - New Rules will Help Strengthen Postmarket Safety Data Collection, that they've issued two proposed rules — one that applies to electronic medical device adverse event reporting, and one that applies to electronic drug and biologic product adverse experience reporting. The proposed rules would not change what types of incidents are required to be reported to the FDA—it would require that the incidents be reported in an electronic format that the FDA can process, review, and archive. Additional Information From the FDA:

• FDA’s Web site on Electronic Medical Device Reporting: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
• FDA’s Web site on the FDA eSubmitter: http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm
• Fact Sheet: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm179586.htm

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Say Maaah - Goats Make Anti-Clot Drug

This could be the shape of things to come, genetically engineered animals turned drug-making machines. This LA Times article, New old-fashioned drug makers: goats, reports that genetically engineered goats produce a human protein that is extracted and turned into a medicine to fight strokes, pulmonary embolisms and other dangerous conditions caused by blood clots. A panel of the Food and Drug Administration voted overwhelmingly that the drug -- called ATryn -- is safe and effective. The FDA is expected to make a final ruling soon. If approved, this would be unprecedented, the drug would be the first from a genetically engineered animal to be approved in the United States. If ATryn gets approved, you can expect to see more milk produced by genetically engineered rabbits and cows for future lines of drugs to treat hemophilia, respiratory disease and swollen tissues. By the way, do goats really say maaah?! 

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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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FDA Draft Guidance On Process Validation

The FDA recently released a draft guidance for new process validation. The guidance says that manufacturers would have to increase sampling and testing, and monitor process performance more closely during the early stages of commercial manufacturing, according to the FDA's Guidance for Industry - Process Validation: General Principles and guidance. Once finalized, this guidance replaces the FDA's process validation guidance issued in 1987. The new guidance applies to pharmaceuticals, biologics and active pharmaceutical ingredients. It will cover the 3 stages of process validation — process design, process qualification and continued process verification. Are you ready? 

Related Posts: Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending FDA Data Guidance - When patients withdraw from clinical trials View more FDA Guidance Documents (free) FDA Draft Guidance On Proprietary Names New FDA Guidance - Residual Solvents in Drug Products New FDA Guidance - New Contrast Imaging Indication Considerations New FDA Guidance - cGMP Practice for Phase 1 Investigational Drugs FDA Guidance Documents - FDA Current Thinking (free) Sign up for FDA Guidance Documents email updates. 

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The FDA On Combination Products (drug-biologic with medical device)

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Updated June 30, 2021

The original link broke.

You can read more about the topic here:

Frequently Asked Questions About Combination Products - FDA.gov

---  the original post follows below  ---

It's hard enough to comply with a single set of regulations. Now it's even harder, if you manufacture a combination product (which has a drug/biologic component and a medical device component). That's because a larger set of rules and regulations have to be followed, says this PharmTech Talk article, "Combo Products Come with More Regs." 

Bottomline, you can expect an increase in "GMP regulatory action along both the laboratory and manufacturing lines." 

Previous Posts: 

Nice Review of US FDA Medical Device Regulation 

Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending 

FDA Guidance Documents - FDA Current Thinking (free) 

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Health And Safety Tips - Before and After A Hurricane

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The FDA has this fantastic collection of free tips and resources if you're potentially affected by a hurricane, "Hurricanes: Health and Safety Before and After a Storm." They offer so many items that I can only skim the surface of what's on the site. Here's the best I can do, here's a listing of the general categories of information they provide . . .

1. Drugs
2. Biological products
3. Food safety
4. Animal health
5. Medical devices
6. And lots of other information sources

Be well, and stay out of harm's way.
 

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