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FDA’s Kessler to Leave but Agency Still Under Fire – WASHINGTON

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 The sometimes controversial head of the Food and Drug Administration, David Kessler, will soon be gone but the agency will not have shed its critics.
Drug and medical device makers are pressing for even simpler and faster approval of their products, while consumer advocates are urging the agency to take a tougher line with those who flout its rules.

Although he probably will be best remembered for spearheading the Clinton administration’s crackdown on the tobacco industry, Kessler did speed up the FDA review process with some prodding from Congress and industry.

He announced late last year he will resign after six years in office and is to leave in late February. A senior FDA official, Michael Friedman, will temporarily lead the agency while the search continues for a permanent successor.

In addition to the sometimes competing aims of consumer groups and manufacturers, there are factions in Congress who would like to strip the agency of some powers.

A drug industry official said a top priority was renewing a user fee act under which drug makers pay about $200,000 per drug to help the FDA hire experts to review drug efficacy and safety. Pharmaceutical Research and Manufacturers Association spokesman Jeffrey Trewhitt told Reuters the law had worked very well, speeding approvals over the past four years from 30 months to the present 18 months.

But he said the goal set by Congress was six months and “if we want the process to improve, we need the law renewed.”

Trewhitt also called for a sharp reduction in the data required in applications for drug approvals, saying they now can run 100,000 to 200,000 pages. “They are asking for way too much information.”

He said drug makers also wanted better harmonization of approval standards worldwide to make it easer for industrial nations to accept each other’s drug trials and documentation.

The consumer advocacy organization, Public Citizen, said it too would like speedier approvals but it also called for a law to give the FDA more power to enforce its regulations.

The Health Industry Manufacturers Association, the device-makers trade group, said it also wanted faster approval times, adding that a large part of the problem was the many details required for new device applications.

“The rules for the application take most of the time,” James Benson, association senior vice president for technology an regulatory affairs, said.

He said the time required for approval of most devices — those with known risks, such as X-ray equipment — was 90 days and the FDA has done a good job. But, he added, problems arise when an application has to be revised.

“If they (the FDA) feel the application is inadequate, the FDA will ask for more information, so the clock stops and goes back to zero,” Benson said. For high-tech products such as heart valves the required timetable is 180 days, but approvals can take up to 700 days, he added.

Health Research’s director, Sidney Wolfe, agreed that a user fee was needed to speed up medical device reviews. But he also said the FDA should be given power to subpoena documents of a drug or device company it suspects of violating FDA regulations, a power now wielded by other agencies, and be given wider authority to levy penalties for violations.

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Health news: What does it take for mental health?

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Health news: What does it take for mental health?

As important as physical health has become in the post-coronavirus world, so has the need for mental health.

New Delhi: As important as physical health has become in the post-Corona world, experts strongly express the need to maintain mental health. Because during the Corona period, people all over the world suffered from various mental illnesses. We are currently living in a different era. You think you should be present everywhere. You have to be connected with everyone. But social networks have made us antisocial, doing more damage than we expected. This is especially true of your mental health.

Meditation is important when it comes to taking care of mental health. Meditation is very easy. If you are interested in learning to meditate, there are many apps. But if your mind cannot concentrate or the confusion in your mind does not subside, then various hobbies should be taken up. There are many options for drawing, knitting, reading books, cooking.

What do you need

It is important to avoid spending too much time on social media. Need to meditate and exercise daily. Concentration can also be gained through reading books. Hobbies increase mental strength.

Website title: health mental health physical health meaning mental health experts citizens ysh

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Lip care tips: make your lips rosy and soft, do this home remedy

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Lip care tips: make your lips rosy and soft, do this home remedy

Lips enhance facial beauty. Lips give your face a complete look. Nowadays people like thick lips. Here are some home remedies for you.

lip care
symbolic photography

Pink and plump lips: Lips enhance facial beauty. Lips give your face a complete look. Nowadays people like thick lips. Therefore, surgery is also performed. But this surgery is very expensive. At the same time, many women undergo surgery. Surgery in such cases can also be dangerous. In such cases, home remedies can be used instead of surgery.

Do this with soft pink lips.

Clove oil
You can soften your lips using clove oil. Some care should be taken when using this oil. Always use clove oil in lip balm. You can also use it by adding 1 teaspoon of clove oil in honey.

Apply moisturizer on the lips.
You can apply moisturizer to make your lips look more beautiful. This will prevent your lips from chapping and will also keep them moisturized. You can also use lip balm for this. This will keep the moisture on your lips and make your lips look very attractive.

menthol trick
You can use the menthol trick on your lips to make them look plumper. This will not harm your lips in any way. Also, your lips will look very soft and pretty.

Cinnamon
You can also use cinnamon oil for the skin on your lips. When you apply cinnamon oil on your lips, it can get a bit irritated and your lips get swollen. In such cases, never apply cinnamon oil directly on the lips. To apply cinnamon oil to your lips, first mix lip balm or Vaseline and then apply it to your lips.

(Note: The information provided here is based on folk remedies and general information. Before adopting, please be sure to consult a doctor.)

Website title: Lip care tips, follow these home remedies to make a rosy and plump prp.

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Don’t do ‘this’ work on the train after 10pm; Otherwise, action can be taken

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Don’t do ‘this’ work on the train after 10pm; Otherwise, action can be taken

Your trip can be more comfortable if every passenger on the train follows the rules of the train.

railway rules
(File photo: Financial Express)

Most of the people in the country love to travel by train. Traveling by train is comfortable and safe. In such cases, you must know all the rules related to railways. The railways establish various rules for the comfort of the passengers. In recent days, the Railway Board has also changed a number of rules for passenger comfort. Your trip can be more comfortable if every passenger on the train follows the rules of the train. Today we will learn some rules related to railways, with which you can make your trip more comfortable.

The middle berth was the most difficult to travel in a tri-level coach. Often the bottom bunk passenger stays in the seat late into the night, so the middle bunk passenger cannot relax despite her wishes. It also happens that middle bunk passengers sit on the bottom bunk late into the night, making it difficult for the bottom bunk passenger to sleep.

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If this has ever happened to you, you may not know the rules of the train. But from now on you can check the rules of the railways. According to railway regulations, you can open the middle bunk from 10:00 p.m. to 6:00 a.m. That is, if you have a lower berth, a passenger in the middle or upper berth cannot sit in his seat after 10 pm You can ask him to go to his seat, referring to the railway rules. In addition, even if a passenger with a middle bunk opens his seat during the day, you can deny it by stating this railway rule.

Many passengers complain that the train TCs arrive late at night to check tickets. In such a situation, your sleep is disturbed. To alleviate this problem and facilitate passenger travel, TC cannot check tickets between 22:00 and 06:00 according to railway regulations. But if your trip starts after 10 p.m., this rail rule does not apply.

A five-year-old girl gave birth to a baby boy; You will be surprised to read the incident.

Complaints from passengers who listen to songs at full volume or watch videos on their mobiles at night reach the Railway Board from passengers. In this context, the railways have banned listening to songs or watching videos without headphones after 10 p.m. As a general rule, after 22:00 you cannot listen to songs or watch videos without headphones. Not only this, it is also forbidden to talk loudly at night.

If your traveling companion does not listen to you, you can complain to the train staff present on the train. It is the responsibility of the railway staff to go to the place and solve your problem. If the passenger still does not agree, then he can be treated according to the rules of the railways.

Website title: Do not do these things on the train after 10 pm, otherwise pvp action can be taken

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