How Do I Know If FDA Approved Drugs Are Safe?

Have you ever wondered where your pharmaceutical drugs come from? How about the amount of testing they go through in order to become legalized in the United States? Maybe you have had issues such as joint pain, and are wondering how safe FDA drugs truly are.  Well, according to the U.S Drug and Food Administration, there are five important steps in the process of creating new prescription medications.

The first stage of FDA approval: Discovery and Development

The first step to creating a new drug is the discovery and development phase. Typically, a new drug is discovered to combat some sort of disease. If new insights are discovered about that disease then there is a good chance that they will be able to create a new product that will either stop or reverse the effects of it. The main goal of a product is to get through initial early testing so that it can move on, into the second part of the first stage. During the development of a new drug, the developers decide what the right dosage would be, how it will be administered, how it interacts metabolically with different types of people and its negative/positive effectiveness as compared to other drugs.

The second stage of FDA approval: Pre-clinical Research

The second stage of creating a new prescription medication is the pre-clinical research stage. During this stage the discovered and developed drug is then transported to a lab to be further tested. A very important thing to note is that drugs rarely ever stay in the same place that they were created. Therefore it is vital that they are transported safely to reach their many different destinations of testing.

Many drugs require different forms of regulatory compliant storage, transport, management and a variety of temperatures. An example of the type of company that would normally transport these drugs would be classified as laboratory movers. They would be responsible for making sure all the drugs are transported without being contaminated, or destroyed. Once a drug is safely transported to the testing lab it is tested to make sure that it won’t cause serious harm to anyone. The specific thing they look for during this stage is the drug’s toxicity through in vitro or in vivo research methods.

The third stage of FDA approval: Clinical Research

The third step in creating a new drug is the clinical research stage. During this stage, clinical trials are designed and conducted on humans. This process is vital so that long and short term effects can be reported about the drug. Without this experimental stage, the FDA would not know if a drug is significantly effective either.

The fourth stage of FDA approval: FDA Review

After a drug successfully makes it through the clinical research stage, it then enters into the fourth step, the FDA Review stage. During this time, a new drug application is submitted to the FDA so that it can be reviewed by the FDA advisory committee. This application includes everything from proposed labeling, safety updates, drug abuse information, and patient information to the directions for use of the drug. After this application is sent, the FDA can decide if it is complete or not. If it is not complete, they can refuse the application. If it is accepted as a complete application, it then takes 6 to 10 months for the committee to decide if it is approved to become a drug.

The fifth stage of FDA approval: Post Market Safety Monitoring

After a drug is approved by the FDA, it reaches its fifth stage. This stage is called Post Market Safety Monitoring. Because of the fact that it is impossible to know the full extensive drug safety from clinical trials, the FDA keeps tabs on its drugs. For example, if any changes are needed to make to the drug more effective, the developers must submit a supplemental application to be re-reviewed by the FDA. They would also have to check with the FDA before they are allowed to use the drug to work against any other diseases that may benefit from it.

How do I know that the FDA is trustworthy?

One way to ensure safety of products being made is by the FDA’s manufacturer inspections. These inspections may be announced or by surprise so that the FDA knows if its manufacturers’ facilities meet the minimum safety standards. Another way that the FDA helps to protect patients is by regulating the advertising and promotion of drugs by the designers. The FDA is very particular about what they allow to be said on advertisements. They do not allow advertisements to be false or misleading. In addition to that, an advertiser is prohibited by law to advertise for unauthorized uses of their product.

What about Generic Drugs?

The good news for the creators of new drugs is that they are provided a patent for their drug for a certain amount of time. During this time, no one else is allowed to create a generic version of their drug. After the patent ends, competitors are allowed to create generic versions of the drugs to sell for cheaper. The FDA requires that the generic drug has the same dosage form, strength, safety, quality, performance characteristics, and intended use. However, since the generic drug is comparative to the original, it does not have to go through the same clinical trials as the original did. Luckily, since a generic drug is required to be so similar, consumers do not have to worry about if it is as safe or as effective. Although some may prefer the original over the generic drug, there is really no difference overall. Looking at all this information, one can be reassured that the FDA takes their drug creation process very seriously and that as consumers we can trust the FDA.

Posted in Health | Leave a comment

What To Do When You’ve Been Injured in a Car Accident


According to the National Highway Traffic Safety Administration, it was estimated that during the first half of 2016 (Jan – Jun) 17,775 people died in motor vehicle traffic crashes. This projected amount portrayed an increase of about 10.4 percent in 2016 as compared to the 16,100 fatalities that were reported to have occurred in the first half of 2015. This statistic alone shows how real and detrimental a car crash can be.

Sadly, this statistic does not include all of the victims of car accidents that live in pain because of an injury they got from driving. Many people silently suffer from pain and have no idea what to do next. Getting into a car accident is scary and stressful enough without having to worry about dealing with everything perfectly so that insurance companies don’t take advantage of you. If you have been in a car accident and are wondering what the next step is, please take note of important do’s and don’t’s as you deal with your personal injury case.

Don’t: believe car insurance is your friend. Do: seek legal help.

First and foremost, do not assume that a car insurance company has your best interest at heart. Many car insurance companies will try to contact you before you get an attorney. Little to your knowledge, they are probably recording your conversation, looking for you to say something that may help them pay less to you in the long run. Many people who do not seek professional legal help may be severely hurt by what they disclose to anyone in the future about their injury and accident.

That is why it is important to get an accident attorney who is an expert on personal injury claims. This is especially true if you feel as though you received an injury during a car accident. When you get an attorney, they will not only help you combat car insurance professionals but they will also help you decide which doctors may be helpful to see as you recover. Remember, this may be your first time dealing with a car accident injury, but it is not theirs. You are going to want someone with experience so be careful as to who you choose. Always take time to get to know the individual that is going to represent you before you hire them. You want to pick someone that you can trust and that will have your best interest in mind.

Don’t: go through it alone. Do: seek professional council.

If you have been dealing with your injury for a long period of time, it can take an emotional toll on you. If you feel like your emotional health is being affected by your injury, it may be time to either ask a family member or friend for emotional support and help. From the very beginning of an accident, it is important to set up a strong support system. If for whatever reason you are not able to get a strong support system, talk to your attorney about the possibility of seeing a professional psychologist or psychiatrist. Having someone to help you through the emotional stress of an injury is half of the battle. Do not worry about insurance because your attorney will be able to answer all of your questions.

Don’t: assume that you won’t get better. Do: stay positive

Another huge mistake people can make is giving up too soon. Because of the emotional pain an injury takes on a person, it is easy to give up when you are not given the results that you’d hoped for. Although doctors can give you a rough estimate of how long it will take heal, they will never be able to predict how long your injury will last. If you are told that you should heal in three to six weeks and four months later you are still in pain, remember that every person is different and that does not mean you won’t heal eventually. Once you become negative about the situation, your chances of healing are a lot less.

Don’t: sacrifice your quality of life. Do: everything you can to ensure you heal properly

Although physical therapy or surgery may sound worse than dealing with the pain you are in, remember that you should never sacrifice your future quality of life for instant gratification. If you refuse to put the work in that it takes to heal, then you will deal with the consequences in the future. Taking the “easy way out” will affect how slowly you heal. The sooner you start listening to the doctors, the sooner you will heal. Your doctors, along with your accident attorney, want you to get better, so it is important that you take their advice when it’s given. Surgery may seem scary but if your doctor suggests it that means it is your last result. Keep in mind that many times, painful, debilitating injuries can be fixed by a simple surgery.

Don’t: assume you don’t deserve financial compensation. Do: remember your life has value.

Many people who are victims of someone else’s recklessness automatically assume that they are not entitled to financial compensation. However, this is a misconception. Insurance companies were created to protect drivers. So when someone that is under their coverage makes a mistake and injures someone else, it is their responsibility to pay for the damages they caused. If you have any kind of an injury that interferes with your quality of life, you should be compensated for it. Your life and your happiness are worth something, even if the injury you sustained works itself out sooner rather than later. That being said, do not assume that a small cut or bruise deserves thousands of dollars. Be realistic and fair. You deserve compensation that reflects the amount of pain that you suffer. All in all, a personal injury does not mean your life is over. With hard work, a good attitude, a support system and a personal attorney, you will find that dealing with your injury is a lot less stressful than you imagined it to be.

Posted in Legal Help | Leave a comment

How To Quickly Recover After A Divorce

You might expect that there would be some changes to your life that you would have to get adjusted to after a divorce. While you may have known that half of all marriages tend to end in divorce, you might not have realized just how much you were going to suffer financially. Regardless, now that you are in the situation you are in, you will want to do everything you can to quickly bounce back. This way, the struggle of your divorce will not continue to affect you longer than it needs to.

Adjusting From The Income Change

If you were a two-income household and are now a one-income household, you are going to have to make some quick adjustments. After all, the marital debt may not have been split right down the middle. Plus, instead of having help with the kids, instead of having your spouse to turn to, you have to hire a babysitter. You may have been forced from the home with the affordable mortgage and had no choice but to move into a small apartment that costs twice as much money each month. There are endless factors that you will have to take into consideration.

You will need to first figure out a way you can improve your monthly income so you can pay off any lingering debts that are causing you trouble. You can seek a promotion at work, put in some overtime hours, or get a second job that you can work on the weekends. You may also need to find a way to obtain some quick cash to handle more immediate needs. This can be done by obtaining one of the best installment loans that you can find.

Benefits Of The Installment Loan

While you may be well aware of the importance of an excellent credit score, your divorce may have temporarily ruined your score for you. With the payday alternative loans, you will still be able to have an installment loan without all of the red tape that you have to jump through with other loan companies.

With a payday alternative loan, all you will need is proof of your income, proof that you have an active checking account, your identification, and your social security number. This is to ensure that you are who you say you are and that you have the means to pay back the loan in a timely manner. One of the best benefits of this type of loan is that they are usually fast-funding. This means that you could have your money tomorrow. Depending on the company and how early in the day you apply, you might even be able to have the cash in your hands the same day.

Take that installment loan money and put it to good use. You can use it to pay off the final bill that was sent to you from your divorce lawyer. You can use it to catch up on some utility bills. Then again, you might just want to hold on to that chunk of money and use it as an excellent starting point for an emergency fund.

It Will Take Some Time

While you may wish that you had never ended up in the financial mess you are in, it is something that millions of people are going through right now. You are not alone. The bright side is that there is always room to improve your financial situation. With some strategic planning and dedication, you will be able to increase your credit score and have all of your expenses back down to an amount that is reasonable for you to handle on your own.

Posted in Love & Relationship | Leave a comment

Recovering from Addiction: Defeat Self-Doubt

It is common for those with addictions to have a lot of self-doubt about their ability to change. Many people turn to drugs initially because they don’t feel they are good enough and leaving the drugs behind can make those fears come flooding back. The fear of failure, fear of success, and fear of rejection can plague those who are starting down the path of recovery. By addressing each fear separately, it is possible to minimize the self-doubt that can make the recovery process more difficult.

Failure

Rehab for men often brings up fears about failure. No matter how long one has been sober, the fear remains that something may cause a relapse that would undo all the effort and hard work that went into the recovery process. This fear can come up in many different ways but the two most common are the fear that it won’t be possible to stay sober at all and the fear that one is incapable of recovery if there is a relapse.

When first contemplating rehabilitation efforts, many addicts will worry it isn’t worth even trying because they are certain that they are not strong enough or good enough to succeed. Having a support network of people who know how to help establish good routines and coping mechanisms can help alleviate this fear and make success seem more possible.

Unfortunately, many people will face challenges throughout their life that will leave them with the temptation to fall back into old habits. It is important to recognize from the beginning that this is a possibility and that while it is not the optimal outcome it is also not the end of the recovery process. The analogy of learning to ride a bike is appropriate. If you fall off the sobriety bike, it simply means you need to get up and try again. Failure is only the final outcome if you quit trying.

Success

Interestingly, many people fear success almost as much as they fear failure. They have doubts that they will be able to enjoy their life if they are sober or that the life they will lead while sober will not be worth the pain and time it takes to achieve it. Going to meetings or talking to those who are at various stages of recovery can be a good way to address this concern. Obtaining first-hand accounts of success can be a great motivator.

The other fear of success is one that many people don’t consciously recognize at first, it is the fear that they don’t deserve to recover. Many people will unknowingly sabotage their own success and even their own lives because of deep feelings of being unworthy. If you find yourself thinking that sobriety and a happy life would be nice but isn’t for you, talking to a therapist independently may help uncover and address the underlying issues.

Rejection

As with the other areas of self-doubt that can make recovery more difficult, the fear of rejection is multifaceted. There may be the fear that family and loved ones will reject your efforts or that your friends who are active in your life of addiction will reject you once you become sober.

Many addicts find that their family and closest friends from the time before they became addicted have lost a great deal of their faith in them. This can make it more difficult to approach those individuals about the process of recovery and rehabilitation. It is important to accept the idea that it may be impossible to mend these relationships and to recognize the goal is one’s personal well-being and happiness, not the acceptance of others.

The fear of losing those with whom one has spent time while using drugs or alcohol can cause a great deal of self-doubt as well. Questions about one’s identity, values, and life experiences will likely come up for addicts in the recovery process. It is possible that the people who choose to stay in that lifestyle will not wish to associate with someone who has gone through the recovery process. However, it is equally possible that as your preferences and choices change that it will be you who wishes for new friends.

The self-doubt that plagues those who are in the process of beating an addiction is all centered around various fears. By recognizing these fears and addressing them as they come up you will be able to push past them to your new life.

Posted in Rehab | Leave a comment

Five Must-Have Coats for Women

Selecting quality outwear is just as important as choosing your normal clothing. Outerwear can protect yourself and your clothes from harsh elements. A coat can pull double duty and make a fashion statement as well. While you don’t need a different coat for each single outfit, it’s good to have a selection that will match your various outfits.Banana Republic offers traditional, stylish, and trendy selections. Here is a list of five must-have coats for fashion-forward women.

A trench coat is great for cold and rainy weather. Trench coats can come in different lengths, like a full-length, below-the-knee version and a sportier, short version. Typical trench coats come with big, roomy, side pockets and a wide belt. Coats can come in a variety of colors, materials, and linings. You can pick a neutral color that will match many of your outfits or choose a bold, bright color to make an impactful statement.

A quality, leather jacket may not seem like a practical choice, but it’s a great option for many outfit types. A short, slim cut leather jacket can be worn over designer jeans and a casual top or over a knee-length dress. It adds a layer of warmth in cooler seasons or inside environments, while turning your casual outfit into something more stylish.

A wrap jacket can be different lengths, colors, and styles, but its typical style is a looser style that wraps around your body, with a collar and wide belt. Depending on what type of outfit you’re pairing it with, you can choose a lightweight wrap to cover a short-sleeve, fancy dress or a turtleneck and jeans. Since the jacket is a wider style, it looks wonderful paired with a slim-cut outfit, dress, jeans, or pants.

A denim jacket is an old-time favorite. Denim coats can be a short cut with fitted body and short collar. Or they can be below-waist length with a wide collar and slouchy, side pockets. Different denim colors can match a variety of outfit colors. You can’t go wrong by pairing this coat over a summer, lightweight dress, shorts and a tank top, or over designer jeans and sequined top. It makes your casual outfit look more pulled together and trendy.

A wool peacoat is a classic jacket. It typically has a wide collar, a straight body shape, and rows of buttons down each side. The length falls below the waist or around the upper thigh. It’s perfect in colder seasons to keep warm while looking good. Colors range from neutral tan or black to bold coral. It can be worn with both casual, business, or dressy outfits. It’s pretty when combined with a long shirt and mock turtleneck or over a pair of jeans and long-sleeve blouse.

With these five type of coats, you’ll look good and be protected in every season and every situation.

Posted in Apparel | Comments Off on Five Must-Have Coats for Women

5 Things to Take When Meeting a Divorce Attorney


Divorce is one of the toughest life stages you’ll ever experience. The emotional pressure alone can force unhappy partners back into a loveless or broken marriage, confusing and prolonging the pain and discomfort for everyone involved. There’s no reason why this should happen. Once you connect with the right divorce lawyer and get the ball rolling, the entire process can be completed within just a few months if everyone’s on board. Since Michigan is a no-fault divorce state, it also offers some of the most affordable divorce options. The first step is the initial meeting with your Michigan divorce attorney. Relax. It doesn’t need to be stressful and being prepared can ensure smooth sailing right to the finish line. These are the main five things you’ll need to bring to that meeting.

Tax Returns for Both Sides – if Possible

Your tax returns show much more than just what you earn per year at your job. Tax returns can lead to information on individual or joint investment accounts, pension plans, and other monetary assets that can help fund your freedom. The returns can also help the attorney decide on the alimony and child support you may be entitled to or have to pay. Three years worth of returns is usually enough to bring to this meeting.

Current Pay Stubs

Like the returns, pay stubs can also help your counsel formulate financial support. The stubs show bonuses and commissions as well as compensated benefits such as mileage, phone plans, and meals. Retirement plans and special deductions are also listed on the stubs. Three income stubs per working partner are enough to help your attorney calculate support and alimony.

Pension Plans and Retirement Accounts

If you or your spouse have any open retirement savings accounts, the attorney needs to see those. These accounts can include military or work pension, 401K plans, or Individual Retirement Account (IRA). The most recent statements of these accounts can help your Mt. Clemens divorce lawyer discover which were employer vs mandatory employee contributions. This, in turn, has a bearing on support totals.

Bank Statements, Investments, Real Estate

Your divorce attorney will need to see recent bank statements, property forms, and current financial expenses such as credit cards and loan payments. Joint and personal information are required here. Bank and credit union statements will show information regarding loans, social security or pension payments, and direct deposits. This is important because once you’re divorced, you’re responsible for your own bills. And if you happen to make more than your spouse, chances are you won’t want to continue paying the outstanding bills you’re not responsible for just because you forgot to mention them and take your name off the accounts.

Don’t Forget Your Plan

You’ll need to consider several things before the initial divorce meeting, and one of those things will be an after plan. Will your new lifestyle really support full custody, or is joint custody or even visitation a better option for you and the kids? Do you really need the family home or can that go to the custodial spouse? Can the home be sold instead? What about vehicles, education, and career planning? All of these need to be considered prior to that meeting to ensure your divorce will be as quick and painless as possible.

Yes, there are plenty of financial matters to consider here, but that’s a major part of a divorce. The legal agreement doesn’t just end a marriage. It allows each spouse to start separate lives away from each other – on a clean slate. Emotions are usually far too high to handle the financial matters on your own, which is where a Michigan divorce lawyer comes into play. Feel free to get angry, vent, and cry. But don’t let those current feelings keep you and your kids from moving on and having a happy life.

Posted in Legal Help, Love & Relationship, Personal Finance | Comments Off on 5 Things to Take When Meeting a Divorce Attorney