buy cialis

Archive for the ‘FDA’ Category

USP Workshop To Focus On Common Approach For Supply Security

Friday, May 4th, 2012

The U.S. Pharmacopeial Convention (USP) has pulled together a broad swath of  stakeholders for a workshop this month on the complexities of protecting the supply chain. The May 22-23 event in Rockville, MD will feature regulatory officials from Europe, South American, and Africa, and coverage of developing track-and-trace standards, among other ...

Is Item Visibility Needed?

Friday, April 13th, 2012

The Pharmaceutical Distribution Security Alliance (PDSA) has succeeded in bringing together several manufacturers, wholesalers, and pharmacy chains in support of a federal law automating pharmaceutical tracking. Its proposed RxTEC Act would replace the "pedigree" requirements of the Prescription Drug Marketing Act as well as any state laws with ...

Pfizer Explains Birth Control Pill Recall on YouTube

Wednesday, February 1st, 2012

Pfizer took to the Internet today to address its voluntary recall of approximately one million packs of birth control pills. Recalled are 28 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) and Norgestrel and Ethinyl Estradiol Tablets (generic) birth control pills in the United States. Pfizer's Chief Medical Officer Freda Lewis-Hall explained ...

US Pharmacopeia Takes Up Supply Chain Security

Monday, December 19th, 2011

The United States Pharmacopeia is placing supply chain security at the forefront with a new general chapter on best practices for ensuring supply chain integrity and protecting consumers from poor quality and counterfeit medicines. USP General Chapter <1083>, Good Distribution Practices-Supply Chain Integrity, with the recently published USP General Chapter <1079>, ...

December’s New To-Do List: E-Pedigree and Track and Trace

Wednesday, November 30th, 2011

If pharmaceutical electronic pedigrees and track and trace are on your radar, December will be a busy month for you. California's State Board of Pharmacy (CA BoP) has announced that it will discuss implementation of the state's electronic pedigree requirements during its board meeting on December 6. In addition, GS1 ...

Invest in Preventive Maintenance

Wednesday, November 30th, 2011

As the end of 2011 nears, we'll all be looking back to ensure we've wrapped up any unfinished business and making resolutions for 2012. Is preventive maintenance on your list? Or has your schedule slipped? If so, how do you know whether your machinery is still operating to your specifications? Could product ...

Solving Shortages through Serialization

Thursday, September 29th, 2011

The Institute for Safe Medication Practices (ISMP) has surveyed pharmacists and purchasing agents on drug shortages and the "gray" market again, and the bad news is that we could have just reposted our blog on last year's survey and been just as timely. Hospitals continue to struggle with drug shortages, ...

GS1 Standards Pick Up Support

Wednesday, September 14th, 2011

GS1 Healthcare standards are gaining traction. As the latest country to support GS1, India has called for serialized codes following GS1 data formats for exported pharmaceuticals. Most of the top pharmaceutical and medical device companies, wholesalers, and many hospital systems in the US have embraced GS1 Healthcare’s system for product ...

Invest in UDI’s Success

Thursday, August 25th, 2011

Before proposing regulations for unique device identifiers (UDIs), FDA wants to hear from all stakeholders about any barriers and incentives to UDI adoption and use. The agency is holding a public workshop September 12-13 in Bethesda, MD, and while this workshop will not address FDA's UDI regulatory framework, it will ...

Packagers: Get to Know Your 510(k)s

Tuesday, July 26th, 2011

FDA has issued draft guidance to help medical device manufacturers understand when a change to a previously cleared 510(k) device may require a new premarket notification submission. According to the agency, most packaging changes do not require a new 510(k). But there are some areas you should study closely. In the ...