FDA Proposed Guidance for Mobile Medical App

FDA has published guidelines for mobile medical application. This guidance would help FDA scrutinize more on software that claim to turn mobile instrument into medical device.

Purpose of the new guidelines is to address the concern of functionality of medical devices. In guideline FDA gave an example of differences in result of radiological image done with mobile of different screen size. These guidelines would eventually help accuracy of diagnosis. FDA has outlined various definitions of terms such as 'mobile medical application', 'mobile platform' and 'mobile application'.

FDA wants to clear passage for applications that are intended for medical usage but will not risk patients' life if it produces wrong data. That is the reason guidelines have exempted medical reference materials, medical textbook, patient information (such as calorie counter) and app with functionality of medical office.

"Mobile medical app is revolutionary aspect in healthcare industry." said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, in a statement.

Digital healthcare industry has welcomed the guidance.

With this first step FDA has classified mobile medical app in two groups, one is harmful when app fails and another is non-harmful app even if it fails. The step is believed to be significant when world is changing rapidly. Next, FDA would probably come up with more detail guidance for the app that pose risk to one's health if it fails to work as intended.

'Drug Labels & Information Erroneous' Report Consumer Reports Health

A recent study report by Consumer Reports Health said that information in drug label lacked important safety warnings. It was also found that some pharmacies failed to comply with law that requires dispatching drug-guide with medicine.

Consumer Reports Health sent their officers to five top local pharmacies as a part of its investigational program known as "spot check". CRH officers went to refill prescription for the drug Warfarin at fice different pharmacies. Warfarin is one of top selling drugs in USA. It is prescription only anticoagulant drug; it is indicated to prevent blood clotting.


The report is seen as alarming as federal law makes it mandate for pharmacies to provide drug guide along with medicine. It is highly risky to provide prescription drugs without guide. Drug guide is guidelines which include usage, indication, and safety precautions information. All the pharmacies maintained their patient information (which is also must by law), differences were found in safety guidance provided by FDA on Warfarin drug. Accordingly to FDA, Warfarin can lead to deadly health condition if taken with alcohol. Warfarin interacts with alcohol and causes bleeding which may result to death.

Federal law requires drug label for OTC drugs and drug-guide for prescription drugs. Drug label is information which is written in such a way that even laymen can understand (i.e. not using medical terms which are difficult to understand).

CRH also brought into attention that drug labels were also improper and lacked important precautionary information. The investigation was carried out in pharmacies located in New York City only.

Lisa Gill of Consumer Report Health blames lack of specific regulation for such serious issue. Unlike nutrition information provided on food package, there is no such information provided for medicines. Furthermore, FDA does require pharma companies to print drug-label with medicine, but, it does not monitor accuracy of information.

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Generic Drug, What is Generic Equivalent Drug?

What does mean Generic drug?

Generic drug is the bio-equivalent copy of its brand drug version. A pharmaceutical company file patent right application for the drug it has developed. Maximum time span during which patent holder company enjoys exclusive right to produce that drug is 20 years. After that patent expires and other company are legally allowed to produce its generic version with different name, taste, size, shape and color.

Are generics same to its brand in terms of effectiveness and safety?

Yes. Since generic drug is bio equivalent of its brand drug it produce same effects.

What does Bioequivalent mean?

The term bioequivalent refers to the drug which is.....
exactly same to its brand in.....

• Dosage
• Effects
• Strength
• Indications
• Working Mechanism
• Safety Precautions in manufacturing process
• Pharmacokinetics
• Manner to take (liquid, tablets, gel, injection etc)

different to its brand drug in....

• Name
• Shape
• Taste
• Color
• Size

Thus, bio-equivalency means generic drugs are to be taken in same manner to treat certain health condition, same in therapeutic effects, same in mechanism in body and equally safe to its brand.

What are FDA precautions to ensure safety?

• FDA experts are on frequent visit to ensure manufacturing plant meets the monographs.
• Generic drug producer company has to submit result of clinical trials to FDA panel to prove bio-equivalency of generic drug.
• Generic drug must get approval from FDA to get into market
• While on visit FDA experts determine purity and safety of raw materials.

Why generic drug is different in appearance and taste?

Appearance properties of brand drug is protected by intellectual property right. Rights of intellectual properties are also applicable in 148 countries as per TRIPs (Trade-Related aspects of Intellectual Property rights). Patent protection on formulation of brand drug expires after 15-20 years but intellectual properties protection remains forever. This makes a generic drug different in appearance and taste from brand drug.

What about safety of generics manufactured in foreign countries (India, china, Israel)?

There are two groups (PRMA: Pharmaceutical Research and Manufacturers of America and GPhA: Generic Pharmaceutical Association) that monitor both American and foreign drug manufacturing plants to ensure that drug-maker adhere safety precautions outlined by FDA. Inspection includes cross check of raw material suppliers.
generic pharmacy

Trial Begun for Anti-HIV Drug Derived from Plants

Anti HIV drug is being tested on human to checkout its therapeutic effects ans safety. The new drug contains substance derived from a genetically developed plant. It has not been named yet.

Drug contains protein called as monoclonal antibodies. These bodies are derived from a plant which is genetically modified. Drug developers believe that the drug can treat HIV infection. A research study has further delighted developers by stating that affordable production of such antibodies is possible.

It is unknown whether FDA has approved this trial. But in UK trial is going on with approval from MHRA- a UK government regulatory body.

Trial is a part of a project initiated 7 years back known as Pharma-Planta. Goal of this project is to use genetically modified plants for development of drugs that are not feasible to manufacture at low cost. These medicines, highly effective also, can be of great help in developing countries where people can't afford high cost drugs.

WHO estimates death toll around 1.7 millions children of age below 5 years. The cause of death is disease that is preventable by vaccine. ed medicine

The antibodies are derived from GM plants of tobacco. These plants were grown in-house in Germany. In house farming of plants significantly reduces risk of contamination to other plants.

Production of antibodies from GM plants is much cheaper than the production of same antibodies by conventional method" says Julia Ma, co-coordinator of Pharma-Planta project.

The Trial

The trial includes eleven women. Two women of them were administered by antibodies and one with dummy. Intention of the trial is only to ensure antibodies (P2G12) are not harmful.

Twin Effects Drug, for Diabetes & Heart Disease

The new proposed drug would increase good cholesterol level as well as lower blood sugar level. Single drug would lower the risk of both most widely used diseases.

Experts on board, who are monitoring the effects of the drug in trials, are very positive about the therapeutic effect and believe that drug would be of real help.

Millions of people across the world are suffering from diabetes. Most common causes of diabetes are binge eating (or junk food), less exercise, fast life. These all factors eventually results in deadly heart disease.

Statins are most prescribed medicine to treat high level of bad cholesterol. Statin drugs are so far most effective medicine for heart disease like heart attack.

The drug of this new class is currently under trial. Working mechanism of this new drug, generic name of the drug is torcetrapib, is quite different from the other cholesterol lowering drugs. The new class is known as Cholesterylester transfer protein inhibitors (CETPs).

Torcetrapib showed promising result in trial. Level of good cholesterol found to be 65%-66% higher in patients administered with torcetrapib. Like many other treatments Torcetrapib also taken with statin drug.
Lower bad cholesterol (LDL) and higher good cholesterol (HDL) is good condition for heart. Mechanism of HDL ensures softness of blood carrying arteries.

Apart from increasing HDL, the drug also lowered sugar level by 7%. On the other side, sugar level showed no chage in patients with statin medicines only.

Trial for the similar drug was terminated as the drug found to be causing cardio problems. Later, scientists found that the negative-cardio effect was because of the drug and not class of the medicine.

Other drugs of the same class and under development are Anacetrapib and Dalcetrapib.

Currently cholesterol lowring drug generic lipitor tops the list of top selling medicine chart in USA. It would be interesting to see the market of the new drug (if it makes through).