FDA Issues 22 Warning Letters to Web site Operators

FDA’s Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers.

Reason:

None of the Web sites are for pharmacies in the United States or Canada.

What did the agency issued?

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law.

Guidelines for Secure Use of Social Media by Federal Departments and Agencies, v1.0

Risks

Federal Government information systems are targeted by persistent, pervasive, aggressive threats.

In order to defend against rapidly evolving social media threats, departments and agencies should include a multi-layered approach in a risk management program, including risks to the individual, risks to the department or agency, and risks to the federal infrastructure.

Social media technologies such as Wikis, Blogs, and social networks are vulnerable to the following methods/techniques of cyber attacks: Spear phishing, Social Engineering, and Web Application Attacks

The Threat

Federal Government information systems are targeted by persistent, pervasive, aggressive threats. This is well known and documented, as stated in May of 2009 by Margaret Graves, Acting CIO for the Department of Homeland Security.

Recommendations

The following are a series of strategies and recommendations for federal departments, agencies, and policy makers to minimize risk.

Policy Controls

The safe use of social media is fundamentally a behavioral issue, not a technology issue.

Policy addressing behavior associated with protecting data would likely cover current social media technologies as well as future technologies. Policies for Web 2.0 technologies, blogs, wikis, social media sites, mash-ups, cloud computing, Web 3.0, outsourced e-mail, and other new technologies will remain extensible and applicable.

Acquisition Controls

When Federal agencies use hosted information systems, such as social media websites, they must have some level of risk management, mitigation, and acceptance of residual risk.

Most social media websites have a service subscription model that provides additional capabilities, or may be able to provide federal agencies with additional capabilities for a fee. This has already been demonstrated through modifications to Terms of Service (TOS) agreements by GSA.

http://www.cio.gov/Documents/Guidelines_for_Secure_Use_Social_Media_v01-0.pdf

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies

The U.S. Food and Drug Administration today announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics.

The draft guidance for industry titled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications”:

• provides FDA’s current thinking on the format and content that industry should use for submissions of proposed REMS
• describes each potential element
• includes preliminary information on the content of assessments and proposed modifications of approved REMS
• describes REMS policies for certain regulatory situations
• informs industry about who to contact within FDA about a REMS
• indicates FDA Web sites where documents about approved REMS will be posted
• provides an example of what an approved REMS might look like for a fictitious product.

Check out for draft guidance at -

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf

Companies meet deadline to file financial data in new format

In January 2009, SEC finalized a rule requiring public companies to use extensible business reporting language, or XBRL, to submit financial information to the agency’s public financial reporting Web site, EDGAR.

During first phase of the three-year process included more than 425 public companies with a worldwide public common equity float in excess of $5 billion.

By 2011, between 10,000 and 12,000 companies are expected to submit statements in XBRL.

Source: http://www.nextgov.com/nextgov/ng_20090921_4858.php?oref=topstory

FDA Issues Final Regulation on Dental Amalgam

The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of the device.

Specifically, the FDA recommended that the product labeling include:

• A warning against the use of dental amalgam in patients with mercury allergy;
• A warning that dental professionals use adequate ventilation when handling dental amalgam;
• A statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.

Source: FDA

Quality System Inspection Technique (QSIT) :FDA

According to the FDA, 30% of the 10 most frequent observations in Form 483s issued for QSIT inspections are related to CAPA, and 50%  are CAPA-related for non-QSIT inspections.

See webinars which can help device makers to ensure quality standards

1. CAPA – The Heart of Your Quality System
2. CAPA systems in Post Marketing Surveillance
3. Root Cause Analysis for CAPA Management (Shutting Down the Alligator Farm
4. How CAPA and complaint handling should interact in Medical Device – Simplification of the processes is often needed to preserve their effectiveness
5. Preparation of a corrective action/preventive action plan (CAPA) in Drug Safety/Pharmacovigilanc

Tight Regulation Over Cigarettes: Got Approved

More than four decades after the surgeon general declared smoking a health hazard, the Senate on Thursday cleared the final hurdle to empowering federal officials to regulate cigarettes and other forms of tobacco for the first time.

The Congressional Budget Office has estimated the new law would reduce youth smoking by 11 percent and adult smoking by 2 percent over the next decade, in addition to reductions already achieved through other actions, like higher taxes and smoke-free indoor space laws.

Law gives power to FDA:

• Law would give the F.D.A. power to set standards that could reduce nicotine content and regulate chemicals in cigarette smoke.
• The law also bans most tobacco flavorings, which are considered a lure to first-time smokers.
• The law would also tighten restrictions on the marketing and advertising of tobacco products.
• Colorful ads and store displays will be replaced by black-and-white-only text.

Beginning next year, all outdoor advertising of tobacco within 1,000 feet of schools and playgrounds would be illegal.

What Cigarette Makers required to do:-

Cigarette makers will be required to stop using terms like “light” and “low tar” by next year and to place large, graphic health warnings on their packages by 2012.

Source: The New York Times

FDA revises ICH Q8 guidance

The FDA has revised its guidance on ICH Q8, adding an annex that clarifies the original document and adds the principles of quality by design (QbD).

The US Food and Drug Administration’s (FDA) guidance states that different drug delivery methods will have varying CQAs, such as adhesion properties for transdermal patches, but raw materials such as excipients and intermediates are common factors.

Using the framework devised by the International Conference on Harmonisation (ICH) the guidance details the importance of identifying CQAs and using knowledge of them to guide product and process development.

Source: in-pharmatechnologist

Vermont Gov. Jim Douglas signed a bill toughest controls in the country on financial relationships between doctors and industry

The bill imposes more restrictions on gifts from pharmaceutical and medical devicemaker firms to doctors, and demands more detailed financial disclosure of consulting and research contracts between the two parties.

Law Allow

The law does allow, however, for free drug samples; distribution of peer-reviewed academic, scientific or clinical articles or journals serving a true educational function; or financial support for med students, residents and fellows to attend educational or policymaking get-togethers.

Compliance trainings :FDA

Looking for FDA Compliance related training  then have look into following urls

All Trainings in FDA Compliance

1. Successful FDA Pre-approval Inspections of Computer Systems
2. The Pre-IND Process: Changes in Working with the FDA and Regulatory Procedures
3. Auditing the QC Microbiology Laboratory for FDA Compliance
4. What will FDA expect and request from your firm during Design Control portions of Inspections

Click here for more – ComplianceOnline