Philips Gets FDA Warning Letter Involving Defibrillators
Royal Philips Electronics NV (PHIA.AE) has received a U.S. Food and Drug Administration warning letter citing inadequate responses to issues with the company’s emergency defibrillators, including problems linked to deaths. The letter to Philips said the FDA found multiple violations during an inspection at the company’s Seattle facility last year. The letter also addressed issues […]
Read More »Category : News
FDA must use caution with biosimilars
At the Kidney Cancer foundation we’re constantly seeking new ways to ensure those with cancer have access to the best medical data and medicines possible. For the past 20 years, we have served as a source of support and information for individuals and their loved ones affected by kidney cancer and related illnesses. May 11 […]
Read More »Category : News
Sanitation spotty at H&P, say ex-workers
A former quality control inspector at H&P Industries says she regrets not having told government authorities about unsanitary conditions she saw in 2010 at a Hartland factory that was shut down last week after federal regulators said the medical products made there “may pose a risk to public health.” May 11 Top Selling Webinar – […]
Read More »Category : News
After losing FDA battle, ReGen files for bankruptcy
A Hackensack-based medical device maker has filed for Chapter 11 bankruptcy protection, succumbing to financial pressure after the federal government yanked approvals for its flagship product. ReGen Biologics Inc., which filed reorganization April 8 in a federal court in Delaware, listed $5.2 million in debt, but only $1.5 million in assets. May 11 Top Selling […]
Read More »Category : News
FDA’s fast track medical device approval system under fire
The FDA is falling short in how it handles recalls of risky medical devices, a new report from the Government Accountability Office concluded, adding to the ever-mounting criticisms of the agency’s fast-track, 510(k) approval process. The FDA doesn’t keep track of the reasons devices such as hip implants are recalled, and it doesn’t always follow […]
Read More »Category : News
Optimer drug gets 6-month FDA review
Jan. 24, 2011: SAN DIEGO (AP) — Optimer Pharmaceuticals Inc. said Monday the Food and Drug Administration will give the company’s potential bacterial infection drug Fidaxomicin priority review. Under priority review, the FDA aims to review a potential drug within 6 months instead of the usual 10-month period. Optimer expects an FDA decision by May […]
Read More »Category : News
Clinical Data gets FDA OK for depression drug
Jan. 25, 2011: NEWTON, Mass. Biotechnology company Clinical Data Inc. said Monday the Food and Drug Administration approved the major depressive disorder treatment Viibryd. Clinical Data shares surged more than 40 percent in pre-market trading. The Newton, Mass, company said the drug should be available in U.S. pharmacies in the second quarter. Clinical Data holds […]
Read More »Category : News
FDA Panel to Vote on Risk of AEDs
Jan. 25, 2011: WASHINGTON — Injuries and deaths from malfunctioning automated external defibrillators (AEDs) could have been avoided if the devices were approved through a more stringent review process, FDA staff reviewers said. On Tuesday, an agency advisory committee will vote on whether AEDs, now in the high-risk Class III device category, should be moved […]
Read More »Category : News
BioSante gets orphan status for skin cancer vaccine
Jan 25 (Reuters) – BioSante Pharmaceuticals Inc (BPAX.O) said its vaccine to treat skin cancer received orphan drug designation from U.S. health regulators, sending its shares up about 10 percent in pre-market trade. The orphan drug designation for the melanoma cancer vaccine is the specialty pharmaceutical company’s fourth orphan drug designation for its portfolio of cancer […]
Read More »Category : News
Teva Receives FDA Action Letter For Generic Lovenox®
Jan. 25, 2011: JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that it has received correspondence from the U.S. Food and Drug Administration (FDA) regarding the Company’s abbreviated new drug application (ANDA) for generic Lovenox® (enoxaparin sodium) injection. The receipt of this action letter, called a Minor Deficiency letter, indicates that the FDA has […]
Read More »Category : News
