OTC/PN Member Login

Fierce Pharma Manufacturing

Find the latest pharmaceutical manufacturing news on automation & control, supply chains, GMP, anticounterfeiting, and other pharma manufacturing news.

August 17, 2011

Print E-mail

New cause found in most recent Tylenol recall

"Manufacturing failures emerge from the line; quality failures emerge from the boardroom"

click to read

 

 

March 29, 2011

Print E-mail

P&G/Teva manufacturing savvy threatens J&J

"Procter & Gamble's plan to ride Teva's manufacturing expertise shows just how valuable a manufacturing operation can be. That's not to say that the ops boost for P&G is the essence of the joint-venture deal struck late last week by the two. Teva will enjoy the ride in P&G's marketing and brand management limo.

click to read

 

December 1, 2010

Print E-mail

J&J Plant Report Renews Calls for Consent Decree

"Donald Riker, president and founder at On Point Advisors, says the decree in this case is necessary to enforce manufacturing and quality assurance regulations...Riker of On Point says the most recent 483 comments "continue to reflect a widespread systemic failure of a rogue manufacturing operation trying to fix itself."

click to read

 

 

October 26, 2010

Print E-mail

Consent Decree Trumps Prosecution in Some Cases

"Riker, using his OTC Product News platform, has called for the FDA to seek a judicial consent decree governing J&J's manufacturing of OTC products. 'Despite warning letters, FDA monitoring and plant shut-downs it's time for the public health to come first,' he writes."

click to read

 

September 29, 2010

Print E-mail

Weldon Preps for Congress; Denies "Systemic" J&J Quality Problem

"Evidence speaks for itself," says Donald Riker, president at healthcare industry consultancy On Point Advisors. J&J has "embarked on a review of its entire operation and appointed a senior manager over all QA, presumably changing reporting relationships, hiring new people, putting in new SOPs." Riker in July called the Tylenol recalls a "rolling blackout," possibly the result of a "systemic failure."

click to read

 

September 2, 2010

Print E-mail

"The pain patch business is in a kind of regulatory limbo, says Riker. The FDA has issued no final ruling on its regulation, despite a petition by the Consumer Healthcare Products Association...if the FDA ultimately requires NDAs, "Hisamitsu has a big head start," Riker says. The foreign manufacturer has "played by the rules" while domestic manufacturers appear to have "placed their bets on the usual slowness of the FDA and are still playing the clock."

click to read

 

July 15, 2010

Print E-mail

"Healthcare industry consultant Donald Riker, president at On Point Advisors, believes the pallets were sprayed with bleach, dispersing the contaminant into the air and onto the walls and ceiling of plant. In an interview with FiercePharmaManufacturing, he says in an interview it's well known that bleach can convert the TBP in the preservative used on the pallets to the contaminant TBA."

 

click to read

 

July 12, 2010

Print E-mail

"This rolling blackout could be the result of FDA diving into a badly broken systemic failure," writes Donald Riker, president at On Point Advisors, in OTC News. "However, a more cynical view would be that J&J has micromanaged the recall to optimize its inventory pipeline."

 

click to read

 

May 26, 2010

Print E-mail
"If Good Manufacturing Practices are about anything, it's control: Control of equipment, processes, and the activities of those who put the two together to make drugs."

click to read

 
Other OTC/PN News References

The Deal provides unique and proprietary content that serves the news, information, and idea generation needs of corporate and financial dealmakers.

"The Tan Sheet" provides in-depth coverage of news related to nonprescription pharmaceuticals and dietary supplements.

Ad Age is the leading global source of news, intelligence and conversation for marketing and media communities.

Speakeasy Science is a blog about culture and chemistry written by Pulitzer-Prize winning freelance science writer, Deborah Blum.

Insight and analysis covering the nonprescription drugs, dietary supplement and personal care industries.

Philly.com is your source for all Philadelphia. 24-hour breaking news, sports, weather, entertainment and more.

Brand names and brand history for brand consultants and brand marketers. BrandlandUSA helps companies revive brands.

The most widely read and highly cited peer-reviewed Neurology Journal.

Clinical & Experimental Allergy is essential reading for allergy practitioners and research scientists with interest in allergic diseases.

MD Consult brings the leading medical resources into one integrated online service to efficiently find answers to pressing clinical questions.

GMP Coach: your guide to GMP training-related information. GMP news, events, journals; GMP training solutions /concepts.

Business and financial news delivered throughout the day along with investing, financial, CEO, technology, and company information and trends.

Courthouse News Service is a nationwide news service for lawyers and the news media.

Branding is thoroughly covered on Brandweek. From online marketing, CMO news to increasing brand loyalty.

WSJ online coverage of breaking news and current headlines from the US and around the world.

Find breaking news, multimedia, reviews & opinion on Washington, business, sports, movies, travel, books, jobs, education, real estate, cars & more.

Full coverage of Delaware news, sports, business and entertainment in Wilmington, Delaware.

BNET provides actionable intelligence that helps corporate managers and small business owners become effective leaders.

Business News, Stock Market & Financial Advice.

Pharmalot closely follows a variety of topics - drug development; mergers and acquisitions; regulatory oversight and marketing issues.

The latest US and international business, finance, economic and political news, comment and analysis from the Financial Times.



Cheap 3ds Max Entertainment Creation Suite 2012 OEM
Levitra Cialis
Office 2011 Discount
Buy Mudbox for Mac Cheap
Microsoft Office 2007 Home And Student Price
Buy Flash Catalyst CS5
Buy Windows 8 Download
Adobe Cs6 Master Collection Mac
Windows Xp Home Oem
Cheap Adobe Framemaker 10
Download Adobe Director for Mac OEM
Buy Adobe Photoshop CS6 Extended
Buy Oem Software
OTC Product News logo

On Point Advisors, LLC, or its affiliate OTC Product News, provide unbiased opinion on companies, products and events in the OTC industry and receive no financial incentive to promote or influence its opinion of any company or product, and disclose and disclaim any potential conflict of interest herein  (Read full disclaimer)