Regulatory Affairs Syndicator

WCAX - THURSDAY, Nov. 3 (HealthDay News) — Federal health officials heard widely divergent opinions on direct-to-consumer advertising of prescription drugs during public hearings Tuesday and Wednesday, with industry groups claiming the ads lead to better …

WCAX - WEDNESDAY, Jan. 18 (HealthDay News) — U.S. health officials announced Wednesday a major overhaul of the package inserts that accompany prescription drugs. It’s hoped that the changes, designed to be easier to read and understand, will benefit not …

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 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.

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.

Reuters - WASHINGTON (Reuters) - The pharmaceutical industry must embrace, not avoid, new ways to collect and monitor information on drug risks if it wants to continue to thrive and innovate, several U.S. health experts said on Wednesday. Regulatory experts …

Regeneron Pharmaceuticals Inc. has been granted fast-track approval by the government for a therapy developed to treat pain, swelling and redness in patients with rare genetic disorders, the company announced …

Abbott Vascular Inc. said Wednesday its stent placement to treat severe peripheral arterial disease below the knee has been cleared by the Food and Drug Administration for clinical trials in hospitals throughout the country.

The pharmaceutical industry must embrace, not avoid, new ways to collect and monitor information on drug risks if it wants to continue to thrive and innovate, several U.S. health experts said on Wednesday.

(AP) SAN JOSE, Calif. The Food and Drug Administration approved a clinical trial to study the use of a minimally invasive stent - made by a unit of Abbot Laboratories Inc. - for use below the knee, the group sponsoring the study said Wednesday.

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 …

The Food and Drug Administration says a decision doesn’t mean a new path to acceptance.

The Food and Drug Administration approved a clinical trial to study the use of a minimally invasive stent — made by a unit of Abbot Laboratories Inc. — for use below the knee, the group sponsoring the study said Wednesday.

WFTV - 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 …

Orange County Register - SACRAMENTO – Dozens of state and federal authorities raided a San Clemente-based drug rehabilitation center on Thursday and this week began sorting through evidence to determine whether to file criminal charges against the owners or employees …