Fda

You may make a fashion statement with that tattoo, but the FDA warns you could also put your health at risk. The regulatory agency issued a warning Wednesday about getting inked after a recent outbreak linked to the family of bacteria called nontuberculous Mycobacteria.  One species of the bacteria, spread through tattoo ink, can cause lung disease, joint infection, eye problems and other organ infections, the FDA said. The infections are difficult to diagnose and require long, intense treatment regiments.

William H. Hoffman, a retired U.S. Food and Drug Administration official, died Monday from septic shock after kidney transplant surgery at the University of Maryland Medical Center. The longtime Ellicott City resident was 81. William Harry Hoffman was born in Baltimore and raised on East Lanvale Street and his grandfather's Owings Mills farm. After graduating from Polytechnic Institute in 1950, he worked briefly as a carpenter's assistant and as a draftsman at Bethlehem Steel Corp.'s Sparrows Point plant, while attending the Johns Hopkins University at night.

The U.S. Food and Drug Administration has approved a new vaccine to prevent the seasonal flu. FluMist Quadrivalent is the first vaccine to contain four strains of the influenza virus - two influenza A strains and two B strains. It is manufactured by Gaithersburg-based MedImmune LLC. The new vaccine containst weakened forms of the virus strains and is administered by a spray into the nose.  Prior to approval of the new drug, other vaccines contained three strains of flu - two A and one B. The addition of a B strain increases the likelihood of protection, the FDA said.

State health officials don't know how often Marylanders use medications mixed in facilities lacking safety oversight, like a Massachusetts facility linked to three deaths here, but a newly passed law could tell them — and help demonstrate a gap in federal regulation. Batches of sterile drugs from so-called compounding pharmacies will be subject to state review under the measure Gov. Martin O'Malley signed this month. And pharmacists and doctors who perform compounding, in which drugs are somehow altered from their Food and Drug Administration-approved form, will face an extra layer of permits and inspections for drugs used in Maryland.

A Jessup seafood processor that had been ordered by the Food and Drug Administration to stop operations because it wasn't complying with federal safety laws will resume normal business Thursday with a new food handling plan. The agency said Congressional Seafood Co. Inc. did not document that fish were refrigerated at correct temperatures, failed to keep fish species separate to avoid cross-contamination and did not keep sanitation records. The company delivers seafood in Virginia, Pennsylvania, New Jersey and Washington.

The Food and Drug Administration is calling on pharmaceutical firms to give more attention to the potential for abuse of new drugs when subjecting them to pre-market testing. The agency this week released a draft of new voluntary guidelines to assist drug makers in figuring out which compounds should be placed under the Controlled Substances Act, which regulates the handling, record-keeping and dispensing of controlled substances. The guidelines urge researchers to look beyond traditional indicators such as whether a compound is addictive to other characteristics that could lead to abuse.

From the Maryland Politics blog: The number two official at the Food and Drug Administration will join the O'Malley administration. Josh Sharfstein, the agency's Principal Deputy Commissioner would lead the state's Department of Health and Mental Hygiene. Gov. Martin O'Malley told Sun reporter Hanah Cho that he is "delighted" that he could lure Sharfstein from a high-profile position at the FDA. O'Malley will make a formal announcement during a press conference DHMH in Annapolis Wednesday morning.

Men now have a new option to treat erectile dysfunction. The U.S. Food and Drug Administration has approved the new drug Stendra to treat the illness that causes problems in the sex lives of 30 million men. It is the first erectile dysfunction drug in a decade. And its reacts faster than other drugs on the market meaning men may be able to add spontaneity back into the bedroom. Men take the drug, which increases blood flow to the penis, as needed 30 minutes before engaging in sex. They'll still have to take some precautions like when taking other drugs on the market.

An adverse reaction to a beauty product might sound like a story line from a bad sitcom, but it happens in real life too. The U.S. Food and Drug Administration wants to know about any products that give you rashes, burns your scalp or turns your skin an unexpected or unintended color. You should report a bad experience even if you weren't following the directions precisely. After all, if you make a mistake, chances are other people may do it too. Many beauty products or cosmetics recommend that consumers test the item in an inconspicuous area before applying it everywhere, which is definitely good advice.

Ralph S. Tyler III, Maryland's insurance commissioner and a former Baltimore city solicitor, announced Wednesday he is leaving state government for a federal post as chief counsel at the Food and Drug Administration. "It was not an easy decision, but the opportunity at the FDA is certainly exciting," said Tyler, who said he brought a sharper focus to consumer protection during his tenure as insurance commissioner. "It includes the opportunity to go back to being principally a lawyer, which is how I spent my professional life, and it is what I enjoy."

In the early 1980s, transit officials in Washington couldn't figure out why traffic on the Beltway would grind to a near halt every day around the exact same time. The usual explanations didn't fit. Then it was discovered that a single driver was to blame. Every day on his drive to work, this commuter would plant himself in the left lane and set his cruise control to 55 mph, the posted speed limit, forcing those behind him to merge right, and you can imagine the effects. To his credit, this driver came forward in a letter to the editor of The Washington Post.

As Massachusetts closed another compounding pharmacy for unsanitary conditions, a report released Monday argued that the state boards that regulate those pharmacies are doing an inadequate job. Released by Massachusetts Rep. Edward J. Markey, the report stems from the national fungal meningitis outbreak linked to a steroid from the New England Compounding Center that has sickened 354 people in 19 states and killed 25. In Maryland, 20 people have...

The Massachusetts pharmacy at the heart of a probe into a deadly meningitis outbreak may have violated federal health laws, U.S. Food and Drug Administration investigators said Friday, saying mold and bacteria were found in areas where drugs were mixed. Cases of fungal meningitis have reached 28 states, including Maryland, where 19 people have been sickened and one has died. The report came as Maryland health officials criticized the oversight of "compounding" facilities like the one in Massachusetts, which make specialized drugs.

That a batch of tainted vials from a single company could put thousands of people across the country at risk for a deadly form of meningitis is a sign the system for regulating pharmacies that mix drug compounds and ship them nationwide needs to be overhauled. Roughly 14,000 people may have received contaminated shots of a steroid used to treat back pain from the New England Compounding Center in Framingham, Mass. So far, 304 people in 17 states have become ill - including 13 in Maryland - and 24 have died, with those numbers expected to rise.

James R. Adams, a giant on Madison Avenue during the years immediately after World War II, once said that advertising is the "principal reason why the business man has come to inherit the Earth. " Surely, the three weeks prior to an election give further reason why modern "Mad Men" still have a lot to say about how people behave at the polls, let alone the marketplace. Those ads for Question 7 that have flooded Maryland's airwaves in recent weeks aren't detached, dry recitations of why expanded gambling is good or bad for Maryland.

Technicians at the Cape Apothecary compounding pharmacy in Annapolis spend their days mixing drugs that are no longer sold commercially or creating specialized batches of medicine for patients such as children who can't handle the normal dose. Federal officials have linked a compounding pharmacy in New England to a multistate outbreak of meningitis that has infected 119 people, including eight in Maryland. The owner of Cape Apothecary said there is a big difference between his storefront drugstore and the New England Compounding Center in Framingham, Mass.: size.

WASHINGTON - Physicians who want to prescribe anti-anemia drugs for cancer patients will have to register and undergo training or risk losing access to the drugs, under a long-awaited risk-management plan unveiled Tuesday by the Food and Drug Administration. The company also will require physicians to collect signed statements from patients attesting that they have been informed about the dangers of the drugs, which can cause tumors to grow faster and have shortened the lives of some cancer patients.

A SENATE committee was treated last week to one of those rare, Mr. Smith Goes to Washington moments, when a seemingly earnest public servant blows the whistle on a government agency that has lost its way. Shockingly, but somehow not surprisingly, the Food and Drug Administration was described by a long-term employee as so hamstrung by management conflicts and sympathy for the industry it regulates that it cannot perform its mission of protecting the...

The U.S. Food and Drug Administration is warning consumers about topical pain relievers such as Bengay, Icy Hot and Flexall. The over-the-counter creams, gels and patches used by athletes and other pain sufferers on sore muscles and joints for warmness and coolness can experience burning pain or blistering. The injuries are rare, but the FDA advises those who experience them to seek medical care. There have been 43 cases reported to the FDA's adverse events database after use of the products containing higher amounts of active ingredients menthol (3 percent)

You may make a fashion statement with that tattoo, but the FDA warns you could also put your health at risk. The regulatory agency issued a warning Wednesday about getting inked after a recent outbreak linked to the family of bacteria called nontuberculous Mycobacteria.  One species of the bacteria, spread through tattoo ink, can cause lung disease, joint infection, eye problems and other organ infections, the FDA said. The infections are difficult to diagnose and require long, intense treatment regiments.