Biomedical Market Newsletter articles from May 2002

Biomedical Market Newsletter archives from May 2002

FBI, IRS & OIG Shut Down Massive Lab & Durable Medical Equipment Operation.
May 31, 2002... Approx. 400 arrests for kickbacks & fraud Largest undercover healthcare investigation ever During the past several months, the FBI has been continuing ongoing efforts to address healthcare fraud through aggressive investigations that...

MAY 08, 2002 -- In the latest in an alarming number of incidents in the medical industry.(counterfeit drug labeled as Epogen[R])(Brief Article)
May 31, 2002... MAY 08, 2002 -- In the latest in an alarming number of incidents in the medical industry, Amgen recently became aware of the existence in the US of a coun-terfeit drug product labeled as Epogen[R] (Epoetin alfa). The 40,000 U/ml vials are in...

April 19, 2002 -- The President today issued the Annual Proclamation for National Organ & Tissue Donor Awareness Week.(Transcript)(Brief Article)
May 31, 2002... April 19, 2002 -- The President today issued the Annual Proclamation for National Organ & Tissue Donor Awareness Week, April 21-27, 2002, which is summarized below: "Statistics show that approx. 60 Americans receive a transplant every day....

Actor Rob Lowe, Emmy nominated star of "West Wing," and his father, Chuck.(chemotherapy education for patients and their families)(Brief Article)
May 31, 2002... Actor Rob Lowe, Emmy nominated star of "West Wing," and his father, Chuck, take a break from filming a video in Los Angeles as part of a new public education initiative called By My Side[TM]: Taking Charge of Cancer Treatment. Rob Lowe has...

April 11, 2002 -- Washington DC -- Sir Elton John, Chairman of the Elton John AIDS Foundation.(funding for AIDS)(Brief Article)
May 31, 2002... April 11, 2002 -- Washington DC -- Sir Elton John, Chairman of the Elton John AIDS Foundation, and Sandra Thurman, President of the International AIDS Trust, testified before the Senate Health, Education, Labor & Pensions Committee, to seek...

June 3, 2002 -- East Greenbush NY -- Regeneron Pharmaceuticals President & CEO Leonard S. Schleifer.
May 31, 2002... June 3, 2002 -- East Greenbush NY -- Regeneron Pharmaceuticals President & CEO Leonard S. Schleifer gestures as he discusses new plant construction with, from left, Rensselaer County Executive Kathline Jimino, New York State Gov. George E....

Medical Device Labeling Regulations Approved By OMB.(Office of Management and Budget)(Brief Article)
May 31, 2002... WASHINGTON DC -- APRIL 16, 2002 -- The FDA has announced in the Federal Register (Vol. 67, No. 73, Page 18630; Docket No. 01N-0267], that its guidance, "Medical Device Labeling Regulations" has been approved by the Office of Management & Budget...

New OTC Rules For OTC Drug Labels Go Into Effect.(over-the-counter medications)(Brief Article)
May 31, 2002... WASHINGTON DC -- MAY 16, 2002 -- New rules went into effect today, requiring that most over-the-counter (OTC) drug manufacturers must display the FDA's new easier-to-read drug facts label on their products. The OTC regulation FDA finalized...

OIG Catches CMS Paying $836,711 To Deported Medicare Beneficiaries.(Office of the Inspector General)(Centers for Medicare and Medicaid Services)(Brief Article)
May 31, 2002... WASHINGTON DC -- APRIL 03 2002 -- A final report released today by the DHHS Office of the Inspector General (OIG) points out that the Medicare program is vulnerable to improper payments for services rendered to deported beneficiaries. The...

FDA Device Shortage Survey Being Conducted.(Brief Article)
May 31, 2002... WASHINGTON DC -- MAY 21, 2002 -- FDA officials announced they will conduct a phone survey to help FDA implement an emergency device shortage program. The effort would focus on products that would be needed to treat patients if there is a...

Coagulation Testing Equipment Receiving Medicare Reimbursement Coverage.(Brief Article)
May 31, 2002... WASHINGTON DC -- JUNE 03 2002 -- Expanded Medicare reimbursement coverage goes into effect on July 1, 2002, for home use of blood coagulation testing equipment by patients who are taking blood-thinning drugs. The Centers for Medicare &...

FDA Releases Notice On Export Certificates.(Brief Article)
May 31, 2002... Deadline for comments: July 29, 2002 Federal Register: May 30, 2002; Vol. 67, No. 104; 37836-37837; Docket No. 02N-0215 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Export of FDA Regulated...

President Bush Announces Laureates of 2001 National Medals of Science & Technology.(George W. Bush)(Brief Article)
May 31, 2002... WASHINGTON DC - May 9, 2002 - President George W. Bush today announced the laureates of the 2001 National Medals of Science and National Medals of Technology, the nation's highest science and technology honors. The National Medal of...

Abgenix Inc (NASDAQ:ABGX).(chief executive officer)(Brief Article)
May 31, 2002... FREMONT CA -- Raymond Withy, Ph.D. was promoted to CEO, from Pres/COO, succeeding R. Scott Greer, who will remain as Chairman.

Abiomed Inc (NASDAQ:ABMD).(personnel)(Brief Article)
May 31, 2002... DANVERS MA -- Fred Zarinetchi, Ph.D. has been promoted to VP of R&D; Karen A. Heffernan has been named Director of Manufacturing Operations, and Zvi Ladin, Ph.D. has joined as VP for Clinical, Regulatory Affairs & Quality Assurance, said Dr....

Active Pass Pharmaceuticals.(chairman)(Brief Article)
May 31, 2002... Ken Galbraith has been elected Chairman, replacing Dr. William Hunter, who is stepping down from the board, said Dr. Peter Reiner, President & CEO.

AdvaMed (NONPROFIT ASSN).(Advanced Medical Technology Association personnel)(Brief Article)
May 31, 2002... WASHINGTON DC -- James Benson, Exec VP of Technology & Regulatory Affairs, recently announced plans to retire in late June. Benson joined the association in 1993 after a 20-year career at the FDA. Meanwhile, AdvaMed board elected Johnson &...

American Medical Technologies Inc (NASDAQ:ADLI).(personnel)(Brief Article)
May 31, 2002... CORPUS CHRISTI TX -- Ben Gallant has resigned his position as CEO and resigned from its Board. John Vickers, COO, was appointed Chairman/Interim CEO.

Antigenics Inc (NASDAQ:AGEN).(president and chief executive officer)(Brief Article)
May 31, 2002... NEW YORK NY -- Russell H. Herndon was recently appointed as its new President & COO.

AST Products Inc. (PRIVATELY-HELD).(employee promotions)(Brief Article)
May 31, 2002... BILLERICA MA -- Jeffrey S Mullen is its new Applications Engineering Mgr, from Inspex Inc, announced Suzanne Conroy, Coatings Group Mgr

AtheroGenics Inc (NASDAQ:AGIX).(personnel)(Brief Article)
May 31, 2002... ATLANTA GA -- Charles A. Deignan was recently promoted to Sr Dir of Finance & Administration.

Bio-Technology General Corp (NASDAQ:BTGC).(employee promotion)(Brief Article)
May 31, 2002... ISELIN NJ -- Christopher G. Clement, CEO & Chairman of Epicyte Pharmaceutical, Inc., has been appointed President/COO, succeeding Virgil Thompson who left BTG in 2000 but remains a member of the Board, announced BTG Chairman/CEO Sim Fass.

California Industrial Medical Council (NONPROFIT).(employee selection)(Brief Article)
May 31, 2002... SAN FRANCISCO CA -- Dr. Susan McKenzie is the new Executive Medical Director of the California Industrial Medical Council (IMC), announced Suzanne Marria, Assistant Director of the California Dept of Industrial Relations, which oversees the...

Celera Genomics Group (NYSE:CRA).(employee selection)(Brief Article)
May 31, 2002... NORWALK CT -- Kathy Ordonez was appointed President, and will retain her responsibilities as President of the Celera Diagnostics joint venture.

Cook Inc.(employee selection)(Brief Article)
May 31, 2002... BLOOMINGTON IN -- Jim Gardner MD, has been named its first Medical Science Officer.

CorSolutions Medical Inc (PRIVATELY-HELD).(employee selection)(Brief Article)
May 31, 2002... BUFFALO GROVE IL -- Darryl L. Landis M.D., MBA, CPE, FAAFP, is the new Sr VP Health Intelligence & Chief Medical Officer, succeeding Richard Vance, M.D., who was recently appointed President & CEO. of CorSolutions.

Dey LP (PRIVATELY-HELD).(employee selection)(Brief Article)
May 31, 2002... NAPA CA -- Raymond Joske is its new VP Marketing, from Bristol-Myers Squibb, said Mel Engle, COO.

ePharmaLearning Inc (PRIVATELY-HELD).(employee selection)(Brief Article)
May 31, 2002... BLUEBELL PA -- Lisa Hanges was recently appointed as its new Chief Operating Officer.

Genta (NASDAQ:GNTA).(employee selection)(Brief Article)
May 31, 2002... BERKELEY HEIGHTS NJ -- Jean O'Connor was named to the new position of VP Quality Assurance, after spending over 20 years at Johnson & Johnson.

Hanger Orthopedic Group (NYSE:HGR).(employee selection)(Brief Article)
May 31, 2002... BETHESDA MD -- Kent Hugill, is the new VP of Marketing & Business Development for its orthopedic and prosthetics division.

Hydrocision Inc (PRIVATELY-HELD).(employee selection)(Brief Article)
May 31, 2002... ANDOVER MA -- Douglas Daniels is its new COO, from Boston Scientific.

Ivax Corp (AMEX:IVX)(LSE:IVX.L).(employee selection)(Brief Article)
May 31, 2002... MIAMI FL -- Richard Denness was appointed to fill the newly created position of VP of Sales & Marketing, from Schering-Plough Corp, reporting to Neil Flanzraich, Vice Chairman & President.

Laboratoire L. Lafon (NASDAQ:CEPH).(employee selection)(Brief Article)
May 31, 2002... PARIS FRANCE -- Alain Aragues recently joined Laboratoire L. Lafon as President & Director General, a French division of Cephalon Inc (NASDAQ: CEPH).

LifePoint (AMEX:LFP).(employee selection)(Brief Article)
May 31, 2002... BRENTWOOD TN -- Theresa Ford has joined as its new VP of Medical Marketing & Sales.

Ligand Pharmaceuticals Inc (NASDAQ:LGND).(employee selection)(Brief Article)
May 31, 2002... SAN DIEGO CA -- Thomas H. Silberg has been promoted to the new position of Exec VP/COO, said David E. Robinson, Chairman/President/CEO.

MedAssets HSCA (PRIVATELY-HELD).(employee selection)(Brief Article)
May 31, 2002... ST LOUIS MO -- Jack Bernard has joined as its new Sr VP Corporate Accounts

Milkhaus Laboratory Inc (PRIVATELY-HELD).(employee selection)(Brief Article)
May 31, 2002... PROVIDENCE RI -- Stephen J. Di Palma has been named CFO, and was previously CFO of Phytera Inc.

Neurotech Development Corp (OTC/BB:NURO).(employee selection)(Brief Article)
May 31, 2002... NEW YORK NY -- Dr. Fredrick Lane was appointed as President of its Doctors4Doctors Inc. subsidiary, and was CEO of Managed Health Systems Ltd.

Organogenesis Inc (AMEX:ORG).(employee selection)(Brief Article)
May 31, 2002... CANTON MA -- Steven B. Bernitz has been named President & CEO and a member of the Board of Directors. He succeeds Dr Michael L. Sabolinski, who will serve as Exec VP.

Orthovita Inc (NASDAQ:VITA).(employee selection)(Brief Article)
May 31, 2002... MALVERN PA -- Antony Koblish is the new President & Chief Executive Officer. Steven Lopez was also recently named VP of US Sales.

Osiris Therapeutics Inc (PRIVATELY-HELD).(Brief Article)
May 31, 2002... BALTIMORE MD -- Dr. Alfred Seidel was recently appointed as Chief Executive Officer.

Panacos Pharmaceuticals Inc (PRIVATELY-HELD).(Brief Article)
May 31, 2002... GAITHERSBURG MD -- Dr David E Martin was recently appointed as its new VP Drug Development.

PPD Inc (NASDAQ:PPDI).(Brief Article)
May 31, 2002... WILMINGTON NC -- Fred Davenport has been promoted to President, and Paul Covington to Exec VP.

Sicor Inc (NASDAQ:SCRI).(Brief Article)
May 31, 2002... IRVINE CA -- Jack Stover has joined Sicor as Exec VP Finance/Treasurer/CFO. He was a partner in the Technology Compass Group.

Specialty Laboratories Inc (NYSE:SP).(Brief Article)
May 31, 2002... SANTA MONICA CA -- James B. Peter, M.D., Ph.D., has stepped down from the positions of Chairman & CEO. Thomas R. Testman is its new Chairman. Douglas S. Harrington, M.D., will become interim CEO. Both Dr. Harrington and Testman are long-time...

Titan Pharmaceuticals Inc (AMEX:TTP).(Brief Article)
May 31, 2002... SOUTH SAN FRANCISCO CA -- Dr Frank Valone is its new Exec VP Clinical Devel/Regulatory Affairs.

US Food & Drug Administration (NONPROFIT).(Brief Article)
May 31, 2002... WASHINGTON DC -- Lester M. Crawford Jr., D.V.M., Ph.D., was recently appointed by DHHS Sec. Tommy G Thompson to serve as FDA Deputy Commissioner. He will be the senior official at FDA, pending installment of a permanent FDA Commissioner. He...

Univ of Texas SW Medical Ctr (NONPROFIT).(Brief Article)
May 31, 2002... DALLAS TX -- Dr. Claus Roehrborn, is the newly appointed chairman of urology.

ViaCell Inc (NASDAQ:VIAC).(Brief Article)
May 31, 2002... BOSTON MA -- Robert J. Silverman is the new Sr VP Commercial Operations. Donald J. Brown has been appointed Sr Dir of Marketing for Viacord, ViaCell's division. David M. Blackett, will serve as Dir of Marketing, says Marc Beer, Chairman/CEO.

Complaints About The FDA Have Increased, But Statistics Are Incomplete.(Statistical Data Included)
May 31, 2002... The FDA Center for Devices & Radiological Health (CDRH) released the CY 2001 Annual Report of its Ombudsman, Les Weinstein, on May 8, 2002. However, absent from the new data is any analysis from the FDA itself, as far as discussing possible...

The FDA Doesn't Even Know Who To Regulate : Inspector General Confirms The Validity Of BMN Study 3 Years Ago.
May 31, 2002... * 16% of companies cannot even be located * Lack of regular inspections will help cripple exports of medical products in the long run We told you so, FDA. More than three years ago. Biomedical Market Newsletter published an exclusive...

Review Of The Accuracy Of The FDA's Official Establishment Inventory.
May 31, 2002... New Inspector General Report Confirms Sloppy FDA Practices & Relying On Erroneous Records Date: Feb. 13, 2002 From: DHHS Office of the Inspector General, Deputy Inspector General for Audit Services Subject: Review of the Accuracy...

Why 100% Of The People Who Visited Your Website Did Not Register For Your Conference, Or Buy Your Product Or Service.(managing electronic commerce)
May 31, 2002... -- Findings from our ongoing research provide helpful hints for improving your press release results -- Our latest tips, insight, data, analysis & guidance for how to generate an improved response rate from your next press release...

FDA Annual Report : Office of Device Evaluation.
May 31, 2002... FY 2001; Released Feb. 2002 Condensed/Edited Version Welcome to our FY 2001 Annual Report. It's a very positive report in many respects. The Office of Device Evaluation approved 53 PMAs last year. This is 10 more than we approved in FY...

FDA Stays Tracking Requirements Final Rule, For Exported Products That May Not Be Sold In The US.(Brief Article)
May 31, 2002... Federal Register: May 14, 2002; Vol. 67, No. 93; Page 34387; 21 CFR Part 1; Docket No. 98N-0583 On May 14, 2002, the FDA announced it is staying the final rule on notification and recordkeeping requirements for anyone exporting human...

Medical Device Tracking Rule.
May 31, 2002... Released: May 15, 2002; Condensed version Federal Register: Vol. 67, No. 94; pp 34720-34721; Docket No. 00N-1034 SUMMARY: The FDA is announcing that a collection of information entitled "Medical Devices; Device Tracking" has been...

FDA Releases Request For Comments On 1st Amendment Rights Of Medical Companies.
May 31, 2002... Deadline for comment: July 30, 2002 Federal Register: May 16, 2002; Vol. 67, No. 95; pp. 34942-34944; Docket No. 02N-0209] SUMMARY: The FDA is seeking public comment to ensure that its regulations, guidances, policies, and practices...

State Petitions for Exemption From Preemption.(Brief Article)
May 31, 2002... Deadline for comment: July 1, 2002 Federal Register: May 30, 2002; Vol. 67, No. 104; pp. 37838-37839; Docket No. 02N-0053] Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Devices; State...

FDA Invites Preparers Of Abbreviated 510(k)s To Work Interactively.(Brief Article)
May 31, 2002... May 28, 2002 The FDA is inviting preparers of Abbreviated 510(k)s for selected devices to develop their Summary Reports interactively with the review division In "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial...

Safety Of New Drugs Cannot Be Known For Many Years.(Brief Article)
May 31, 2002... 20% Ultimately Found to Have Life-Threatening Adverse Effects, Harvard & Public Citizen Find WASHINGTON DC -- MAY 1, 2002 -- 20% of all new drugs are found to have serious or life-threatening adverse effects that are unknown or undisclosed...

FDA Proposes 1st Requirement For Electronic Submissions.(Brief Article)
May 31, 2002... WASHINGTON DC -- MAY 01, 2002 -- The FDA today issued a proposed rule that would require certain labeling submitted for review with new drug applications (NDAs), certain biological license applications (BLAs), abbreviated new drug applications...

Federal Agents Arrest Ambulance Firm On Healthcare Fraud & Money-Laundering Charges.(Brief Article)
May 31, 2002... LOS ANGELES CA -- MAY 31, 2002 -- The owners and operators of Greybor Medical Transportation, a Los Angeles-based ambulance companies, were arrested today after being indicted on federal health care fraud and money laundering charges. The...

FDA Puts Internet Drug Import Operation Out Of Business.(Brief Article)
May 31, 2002... The investigation began over four years ago, when on Oct. 29, 1998, Gerald M. Bevins slowly wheeled his motor home into a McDonald's parking lot outside of San Diego. Investigators note that he wasn't looking for a burger and fries. He was...

Demand For Cosmetic Facial Plastic Surgery Procedures & Prices Are Increasing.(Brief Article)
May 31, 2002... American Medical Association Chicago IL MAY 12, 2002 -- CHICAGO IL -- Demand for cosmetic facial plastic surgery procedures continues to increase, and so does the price, reports a new study in the Spring 2002 issue of the Archives of Facial...

Cost Of Bone Fractures To Hit $35-$40 Bln.(Brief Article)
May 31, 2002... DALLAS TX -- FEB. 13, 2002 -- Osteoporosis and an overall decline in health and agility can place older adults at heightened risk for bone fractures. When those fractures occur, treatment can be complex and healing can be slow. Speaking at the...

FDA Approved 66 New Drug Applications In 2001.(Brief Article)
May 31, 2002... WASHINGTON DC -- The FDA approved 66 new drug applications (NDAs) in 2001, including 10 priority and 56 standard NDAs. The FDA also approved 24 new molecular entities (NMEs). These included 7 priority and 17 standard NMEs in CY2001.

Schering-Plough Signs A Record $500 Mln Consent Decree With The FDA.(Brief Article)
May 31, 2002... WASHINGTON DC -- MAY 17, 2002 -- The FDA today announced that Schering-Plough Corp., its subsidiary Schering-Plough Products, LLC, and two principal corporate officers, have signed a consent decree of permanent injunction, agreeing to measures...

Schering-Plough Enters Into Consent Decree, Issues Statement & Details.(Brief Article)
May 31, 2002... KENILWORTH NJ -- MAY 17, 2002 - Schering-Plough Corp. (NYSE: SGP) today announced that it has reached an agreement with the US FDA for a consent decree to resolve issues involving the company's compliance with current Good Manufacturing...

Antimicrobial Resistance Is Becoming A Menace.(Brief Article)
May 31, 2002... US Centers for Disease Control & Prevention Atlanta GA ach year, approx. 2 mln U.S. patients acquire an infection while hospitalized; approx. 90,000 of these infections are fatal. Many more infections are acquired in nursing homes and other...

FDA Amends Regs To Provide For Approval Of Some New Drugs & Biologicals Based On Animal Efficacy Data.(Brief Article)
May 31, 2002... WASHINGTON DC -- MAY 31, 2002 -- The FDA today announced in the Federal Register, that it has amended its new drug and biological product regulations. The rule is effective June 30, 2002 Certain human drugs and biologics that are intended...

US Market For Medical Diagnostic Test Kits To Pass $5 Bln By 2006.(Brief Article)
May 31, 2002... Business Communications Co., Inc. Norwalk CT Medical diagnostic kits (MDKs) are analytical test kits that are packaged for use on a single-test basis, to test for a wide variety of substances. MDKs bring diagnostic testing capabilities to...

FDA Is Reclassifying Hip Implants.(Food and Drug Administration)(Brief Article)
May 31, 2002... APRIL 30, 2002 -- In a Final Rule published today in the Federal Register, FDA officials announced today they are reclassifying metal/polymer constrained cemented or uncemented hip joint prostheses, to class II from class III. The implants...

Orthopedic Surgeons Are Rethinking Total Hip Replacement Surgery.(age requirements)(Brief Article)
May 31, 2002... American Academy of Orthopaedic Surgeons Rosemont IL Orthopedic surgeons are rethinking traditional wisdom about who is and who is not a good candidate for total hip replacement surgery (THR). [Replacement of the hip bones with an...

Watson Laboratories Signs Consent Decree With FDA, Requiring Corrective Actions Be Taken at Mfg Plant.(Watson Laboratories Inc.)(Food and Drug Administration)(Brief Article)
May 31, 2002... WASHINGTON DC -- MAY 03, 2002 -- The FDA today announced that the drug manufacturing firm of Watson Laboratories, Inc., a Nevada corporation, has signed a consent decree requiring the firm to take all necessary corrective steps to ensure that...

Watson Reaches Agreement With FDA On Terms Of Consent Decree.(Watson Pharmaceuticals Inc.)(Food and Drug Administration)(Brief Article)
May 31, 2002... CORONA CA -- MAY 03, 2002 -- Watson Pharmaceuticals, Inc. (NYSE: WPI) announced today that it has reached an agreement with the US FDA on the terms of a consent decree with respect to Watson's Corona CA manufacturing facility. As expected, the...

FDA Says Abbott Facility Is Not Conforming With QSRs.(Abbott Laboratories)(Quality System Regulation)(Brief Article)
May 31, 2002... ABBOTT PARK IL -- MAY 15, 2002 -- Abbott Laboratories announced today that it has been informed by the US FDA that its Lake County diagnostic manufacturing operations will be found not in conformity with the Quality System Regulation (QSR). ...

Medical Data Chips Implanted Into 3 Persons In Landmark Procedure.(Brief Article)
May 31, 2002... BOCA RATON FL -- MAY 10, 2002 -- Applied Digital Solutions, Inc. (Nasdaq: ADSX; Palm Beach FL) announced that doctors implanted microchips today that contain a means to access medical information in the arms of three members of a Florida...

AdvaMed Endorses User Fees For Medical Product Manufacturers.(Advanced Medical Technology Association)(Brief Article)
May 31, 2002... WASHINGTON DC -- MAY 20 2002 -- The AdvaMed Board of Directors voted unanimously today to support an industry-negotiated user fee plan that will provide the FDA medical device review program with the resources to substantially improve current...

AdvaMed Position Statement On User Fee Proposal.(Advanced Medical Technology Association)
May 31, 2002... On May 20, AdvaMed's Board of Directors overwhelmingly approved a plan to establish fees for medical device premarket submissions. AdvaMed negotiated this plan with FDA based on these core principles: the fees must be reasonable, must provide...

MDMA To Offer Its Own User Fee Proposal.(Medical Device Manufacturers Association)(Brief Article)
May 31, 2002... WASHINGTON DC -- Larry Holden, President of the Medical Device Manufacturers Association, announced the group will release its own version of a user fee program that will provide for discounted user fees and other incentives for small medical...

FDA Performance Assessed By Its Deputy Commissioner.(United States Food and Drug Administration)(Food & Drug Law Institute Education Conference, April 16, 2002)(Transcript)
May 31, 2002... Presentation at Food & Drug Law Insittute Education Conference, April 16, 2002 I am here today to discuss the state of the FDA, less than two months after I joined the agency. That may sound like a tall order, but FDA and I are no...