3 Pharmaceutical Industry CGMP Compliance Trends – April 18, 2011
3 Trends for April 18, 2011, from Pharmpro.com: 1. There is an emboldened FDA intent on measuring up under a keenly interested Congress. · There are sixteen (16) major pharma consent decrees dating from 1989 to 2010. What do they all have in common? No, it’s not bodies in the street. It’s GMP violations. Of […]
Read More »Category : News
J&J issues another recall, for epilepsy pills
Johnson & Johnson issued yet another recall Thursday, this one for about 57,000 bottles of a widely used epilepsy pill, because of complaints about a chemical odor. The health care giant said it is recalling two lots of 100-milligram tablets of Topamax, sold between Oct. 19 and Dec. 28, 2010. The lot numbers are OKG110 […]
Read More »Category : News
FDA finds more blood cancer with TNF blocker drugs
U.S. health regulators have received more reports of rare blood cancer in young patients taking a class of anti-inflammatory drugs used to treat digestive disorders. May 11 Top Selling Webinar – FDA Expectations of Senior Management Save 50% Now with Offer Code 1012199 The drugs, called tumor necrosis factor (TNF) blockers, are used to treat […]
Read More »Category : News
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
