FDA'a latest bulletin

[Chris Ryser]

Monday's Bulletin .............................

GE HEALTHCARE LOANS TO LASERSIGHT IN DEFAULT

GE Healthcare Financial Services has advised LaserSight that its loans to the company are in default. LaserSight currently is unable to manufacture products due to minimal cash, limited inventories and poor financial relationships with vendors. LaserSight is in negotiations with GE Healthcare to restructure its defaulted loans.

Vol. 4, No. 121
Monday, June 23, 2003

[Chris Ryser]

In today;s bulletin ....................................

Vol. 4, No. 118
Wednesday, June 18, 2003

OCULAR APPOINTS STEVE NEIL EXECUTIVE VICE PRESIDENT, CFO

Steve Neil has been appointed vice president and chief financial officer (CFO) at Ocular Sciences, which manufactures soft contact lenses. Neil has 20 years' experience in international finance management leadership. He most recently served as executive vice president of finance, CFO, treasurer and secretary at Sola International.

[Chris Ryser]

In Monday's FDA Bulletin ...........................

DEY TO PAY SETTLEMENT IN MEDICAID FRAUD CASE


Merck subsidiary Dey has agreed to pay $18.5 million to the federal government and Texas to settle allegations that it submitted false pricing information to Medicaid administrators in Texas, the Justice Department announced last week.

Dey noted that the agreement did not constitute an admission of fault or liability in the case in which Justice had alleged that the company had inflated reimbursements. Justice said it was still investigating Dey's actions with respect to Medicaid in other states.

[Chris Ryser]

In Todays FDA Bulletin ..................................

FDA ALLOWS EXPANSION OF PHASE II PERMAVISION TRIAL


The FDA has allowed the expansion of a Phase II clinical trial of Anamed's PermaVision intracorneal lens for the correction of farsightedness. The company may enroll an additional 100 eyes in up to five different sites.

[Chris Ryser]

In TODAY'S BULLETIN ...............................

FIRM'S CLAIMS ON EYE DISEASE CLASSIFY PRODUCT AS DRUG


Vision Group's Precision Vision, intended as a dietary supplement, is a drug based on the disease prevention claims made for the product, the FDA said in a warning letter.

The letter mentions seizure or court injunction as possible outcomes of continued violations. To see it, go to

http://www.fda.gov/foi/warning_letters/g4054d.pdf.

[Chris Ryser]

Electronic records, FDA today

Strategies for Global Electronic Systems: When Is Part 11 Not Enough?
An audioconference
Wednesday, May 28, 2003; 10:30 a.m. – 11:30 a.m., EDT
Cost: $345

Global compliance standards for electronic records and electronic signatures are shifting. The E.U.’s Annex 11 is now more specific regarding electronic systems compliance than FDA’s 21 CFR Part 11, which has been considered the higher standard. This session will identify key Annex 11 requirements governing the use of computers, electronic records and electronic signatures that raise the compliance bar over FDA Part 11 requirements.

This audioconference will compare and contrast the following E.U. regulatory requirements with those outlined in Part 11:

Implementation of electronic signatures
Physical security considerations
Disaster recovery and business continuity practices
Impact of data protection regulations
Manual system replacements
Management of critical data
Register today:

http://www.fdanews.com/calendar/16142.html

[Chris Ryser]

In Today's Bulletin

STARR FINISHES PREMARKET APPROVAL SUBMISSION FOR CONTACT LENS

Starr Surgical has given the FDA the final module of a premarket approval submission for its implantable contact lens. The submission includes data fulfilling the FDA's requirement for a three-year clinical follow-up. The device is used to reduce nearsightedness.

[Chris Ryser]

In today's bulletin .........................

CARL ZEISS, NOTAL VISION SIGN DEAL

Carl Zeiss Meditec has signed an agreement with Notal Vision under which Carl Zeiss Meditec will distribute Notal Vision's device for detecting and managing age-related macular degeneration. Carl Zeiss Meditec plans to begin selling the device in the U.S. this fall.

Vol. 4, No. 85
Thursday, May 1, 2003

[Chris Ryser]

Vol. 4, No. 76

ALCON'S VIGAMOX APPROVED FOR BACTERIAL CONJUNCTIVITIS

The FDA gave the go-ahead to Alcon's Vigamox (moxiflaxacin ophthalmic solution 0.5 percent) following a six-month review, the firm announced Wednesday. The solution is indicated for bacterial conjunctivitis in adults and children ages 1 year and above. The fourth-generation fluoroquinolone antibiotic is effective against Gram-positive bacteria.

[Chris Ryser]

On topday's site................interesting

ENFORCEMENT: Recent criminal and civil cases are evidence of the seriousness of the risks to public health that regulators uncover when responding to Internet drug sales. To date, FDA has initiated the following actions:
372 Internet drug criminal investigations, 90 involve domestic Internet pharmacies.
150 Internet-related drug arrests, 60 involve Internet pharmacies, and 92 convictions, 26 convictions involve Internet pharmacy cases;
100 open Internet drug criminal investigations; 90 sites are under active review for possible regulatory or civil action;
Nearly 200 cyber warning letters have been sent to domestic and foreign online sellers;
5 preliminary injunctions;
15 product seizures;
11 product recalls and the voluntary destruction of 18 illegal products

[Chris Ryser]

Today's Bulletin...............................

Vol. 4, No. 69
Wednesday, April 9, 2003

EFFICACY ANALYSIS, DATA NEEDED FOR ISTA EYE DRUG
The FDA has deemed ISTA Pharmaceuticals' Vitrase (ovine hyaluronidase) "approvable" for the treatment of vitreous hemorrhage but asked the firm to conduct more analysis of existing data and another confirmatory clinical study. The agency also raised concerns related to the drug substance and product specifications, ISTA said.

[Chris Ryser]

On contact lenses.............................................

FDA ISSUES DECORATIVE LENS IMPORT GUIDANCE
Vol. 4, No. 68
Tuesday, April 8, 2003


The FDA has released an alert about imported decorative contact lenses, which are zero-powered or "plano." The document, "Guidance for FDA Staff on Sampling or Detention Without Physical Examination of Decorative Contact Lenses (Import Alert #86-10)," details the agency's safety concerns about the devices. The lenses are considered cosmetics under the Food, Drug and Cosmetic Act, but the FDA believes that some imported lenses may be adulterated. The agency said the matrix in which colorants are embedded may be dangerous. Some lenses also may contain unsafe color additives and may be misbranded because their labeling is false or misleading.

To see the April 4 Federal Register notice of the guidance document, go to

https://://www.fda.gov/OHRMS/DOCKETS...18-nad0001.pdf https://<br /> <br /> To see the g...l0001.pdf.</a>

[Chris Ryser]

LASIK problem in March 31st Bulletin

Vol. 4, No. 62
Monday, March 31, 2003


FTC SAYS LASIK PROVIDERS MADE FALSE CLAIMS

The Federal Trade Commission (FTC) accused two laser-assisted in situ keratomileusis (LASIK) refractive eye surgery service providers of making false claims about the surgery. The commission also proposed consent orders that would stop the companies from making the claims at issue. The FTC said The Laser Vision Institute and LCA Vision, which does business as LasikPlus, made unsubstantiated claims about the benefits, performance and efficiency of the LASIK procedure. For example, the companies said LASIK surgery eliminated the need for glasses and contacts for life and claimed the procedure is less risky to patients than wearing contacts or glasses, the FTC alleged.

[Chris Ryser]

In Today's Bulletin

Vol. 4, No. 55
Thursday, March 20, 2003


BMC INDUSTRIES, YOUNGER OPTICS SETTLE PATENT DISPUTE
BMC Industries' Vision-Ease Lens subsidiary has granted Younger Optics a license to its polycarbonate polarizing patent portfolio. Terms of the deal, which settled a patent infringement lawsuit between the companies, were not disclosed.

[Chris Ryser]

In the latest bulletin............................................

Vol. 4, No. 52
Monday, March 17, 2003

NOVARTIS AG FILES IRISH SUIT AGAINST BAUSCH & LOMB

Novartis AG has filed a patent infringement lawsuit in Ireland's High Court in Dublin against Bausch & Lomb. The suit, which is on behalf of Novartis AG's CIBA Vision eye care unit, alleges that Bausch & Lomb's PureVision contact lenses infringe one of Novartis' Irish patents. Bausch & Lomb said it will vigorously defend its belief that PureVision lens technology is unique and does not infringe the patent.