The FDA has issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the DQSA, which was enacted in November 2013.
Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix...
Allergan announced today that the European Union’s Committee for Medicinal Products for Human...
This draft guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent.
Today, the FDA issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy consists of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists.
Too often well-meaning parents, grandparents and caregivers want to soothe a teething baby by rubbing numbing medications on the tot's gums, using potentially harmful drugs instead of safer, non-toxic alternatives.
Three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.
The FDA has issued a final order reclassifying sunlamp products and ultraviolet (UV) lamps intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices.
The Food and Drug Administration is taking action based on a study that found Lunesta users had problems with driving, memory and coordination up to 11 hours after first taking the drug. Patients are often unaware that they are still drowsy the morning after, according to the FDA.
The agency is discouraging doctors from performing the procedure, which uses an electronic device to grind and shred uterine tissue so it can be removed through a small incision in the abdomen. Known as laparoscopic power morcellation, the technique is widely used to treat painful fibroids, either by removing the noncancerous growths themselves or the entire uterus.
The European Medicines Agency (EMA) has been informed that vials of the cancer medicine Herceptin (trastuzumab), thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries.
Eli Lilly and Boehringer-Ingelheim said that the Food and Drug Administration didn't approve their diabetes treatment empagliflozin because of concerns about a facility where the drug will be made.
I’m the guy who looks down his nose at every new health trend and scoffs at those who embark on low-carb diets or overindulging on pomegranates or chugging wheat grass juice or slathering their hands with anti-bacterial soap, or downing multi-vitamins and supplements like Halloween candy.
The Food and Drug Administration is warning that a stimulant used in treatments for the childhood condition attention deficit-hyperactivity disorder can trigger painful, long-lasting erections in rare cases.
The U.S. Food and Drug Administration is implementing a plan to help phase out the use of medically important antimicrobials in food animals for food production purposes, such as to enhance growth or improve feed efficiency. The plan would also phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs.
This class action seeks to recover damages against the Company and certain of its officers and directors as a result of alleged violations of the federal securities laws.
Health officials are reporting four Tennessee cases of a rare infant illness that have been linked to parents refusing a routine Vitamin K shot for newborns.
For decades, if you asked your doctor what your odds were of suffering a heart attack, the answer would turn on a number: your cholesterol level. Now the nation's first new heart disease prevention guidelines in a decade take a very different approach...
The Shiga University of Medical Science has become the third Japanese institution to conclude that a clinical study report on Novartis Pharma K.K.'s Diovan blood pressure-lowering drug contained doubtful data and was inappropriate, largely because a Novartis employee participated in the study.
The FDA is recommending new restrictions on prescription medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S. In a major policy shift, the agency said in an online notice Thursday that hydrocodone-containing drugs should be subject to the same restrictions as other narcotic drugs like oxycodone and morphine.
The Food and Drug Administration is appealing to dog and cat owners for information as it struggles to solve a mysterious outbreak of illness and deaths among pets that ate jerky treats. In a notice to consumers and veterinarians published Tuesday, the agency said it has linked illnesses from jerky pet treats to 3,600 dogs and 10 cats since 2007. About 580 of those pets have died.
The FDA has approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection.
The Food and Drug Administration is requiring stronger warning labels on prescription painkillers like OxyContin and Vicodin, in the government's latest attempt to reduce overdose deaths caused by the long-acting medications.
U.S. health regulators are warning doctors and women of child-bearing age that half-a-dozen medications used to treat migraine headaches can decrease children's intelligence if taken while their mothers are pregnant. The Food and Drug Administration said Monday that the drugs, including Depakote and Depacon, should never be taken by pregnant women for the prevention of migraine headaches.
President Barack Obama has proposed a $3.8 trillion budget for fiscal 2014 that aims to slash the deficit by $1.8 trillion over 10 years, raise taxes on the wealthy and trim popular benefit programs including Social Security and Medicare. The numbers do not reflect automatic annual spending cuts of 5 percent for domestic agencies and 8 percent for defense.
President Barack Obama is proposing a new investment into research to map the human brain in hopes of unlocking some of its mysteries, a senior administration official says. The president planned to propose a $100 million investment for next year during an announcement at the White House Tuesday morning, the official said.
Popping calcium and vitamin D pills in hopes of strong bones? Healthy older women shouldn't bother with relatively low-dose dietary supplements, say new recommendations from a government advisory group. Both nutrients are crucial for healthy bones and specialists advise getting as much as possible from a good diet.
Shares of Dynavax Technologies Corp. fell by more than a third after the company said the Food and Drug Administration won't approve its hepatitis B vaccine Heplisav unless Dynavax provides more information showing the drug is safe. Dynavax said the FDA is concerned about the possibility of "rare autoimmune events" in patients.
- Page 1