Regulatory Affairs Syndicator

As the Food and Drug Administration prepares to approve the first vaccine against infections that cause a majority of cervical cancers, religious conservatives are rallying to keep the vaccine from being …

New Braunfels Herald-Zeitung - SAN FRANCISCO (AP) — The approval of the generic form of a biotechnology drug rekindled fierce debate within the pharmaceutical industry and Washington over how federal regulators should handle similar applications as patents expire on billions of …

Birmingham Business Journal - Seventeen months after researchers at Southern Research Institute received U.S. Food and Drug Administration approval for its sixth cancer fighting drug, clofarabine, the European Commission announced today it has granted Bioenvision Inc. marketing …

A statistical “signal” links Risperdal and other schizophrenia schizophrenia drugs to pituitary tumors, FDA researchers report.

WASHINGTON (AP) — The Food and Drug Administration issued its long-awaited decision on a new human growth product with an approval, but at the same time stressed that this action doesn’t set a precedent for other biological medicines.

The approval of the generic form of a biotechnology drug rekindled fierce debate within the pharmaceutical industry and Washington over how federal regulators should handle similar applications as patents expire on billions of dollars worth of drugs.

Dr. Andrew von Eschenbach, the acting head of the Food and Drug Administration, announced Wednesday he would resign next month from his other job as director of the National Cancer Institute.

The Food and Drug Administration issued its long-awaited decision on a new human growth product with an approval, but at the same time stressed that this action doesn’t set a precedent for other biological medicines.

The European Commission (EC), the European Medicines Agency (EMEA) and the U.S. Food and Drug Administration (FDA) have agreed to a procedure for joint FDA EMEA briefing meetings with sponsors following voluntary submission of genomic data. [click link for full article]

KIRO-TV - WASHINGTON — The Food and Drug Administration issued its long-awaited decision on a new human-growth product with an approval, but at the same time stressed that this action doesn’t set a precedent for other biological medicines. Approval of …

The approval of the generic form of a biotechnology drug rekindled fierce debate within the pharmaceutical industry and Washington over how federal regulators should handle similar applications as patents …

Dr. Andrew von Eschenbach, the acting head of the Food and Drug Administration, announced Wednesday he would resign next month from his other job as director of the National Cancer Institute.

The Food and Drug Administration issued its long-awaited decision on a new human growth product with an approval, but at the same time stressed that this action doesn’t set a precedent for other biological …

WASHINGTON (AP) - Dr. Andrew von Eschenbach, the acting head of the Food and Drug Administration, announced Wednesday he would resign next month from his other job as director of the National Cancer Institute. His resignation from the NCI will be effective June 10, said Christina Pearson, a spokeswoman for the Department of Health and Human Services. Von Eschenbach’s holding of both positions -

CBS News - (AP) The approval of the generic form of a biotechnology drug rekindled fierce debate within the pharmaceutical industry and Washington over how federal regulators should handle similar applications as patents expire on billions of dollars worth of …