FDA seeks candidates for medical officer positions in Washington, DC, area
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The Divisions of Antiviral Drug Products (DAVDP), Special Pathogen and Immunologic Drug Products (DSPIDP), and Anti-Infective Drug Products (DAIDP) are seeking medical officers. Position offers the opportunity to provide scientific and regulatory guidance to sponsors at all phases of drug development from clinical trial design to evaluation of clinical trial data submitted for product approval. Range of products for each division is as follows: DAVDP — includes all antiviral drug products for AIDS, hepatitis, herpesviruses, influenza, smallpox, and other viral diseases (physicians with clinical or research experience in hepatology are encouraged to apply). DSPIDP — includes fluoroquinolones, antiparasitics, antifungals, antimycobacterials, agents for peptic ulcer disease, opportunistic infections, transplant, and chronic fatigue syndrome. DAIDP — includes oxazolidinones, glycopeptides, streptogramins, drug products for sepsis, drug products for Lyme disease, macrolides, cephalosporins, monobactams, penems, penicillins, aminoglycosides, topical and otic antimicrobials. A multidisciplinary team approach facilitates interaction with a wide range of scientific disciplines. The position of Medical Officer involves working with the pharmaceutical industry, individual investigators, other government agencies and academia. The position also offers opportunities to work on a variety of initiatives including antimicrobial resistance and bioterrorism. Training is offered and encouraged.
Qualifications: Applicants must have a Doctor of Medicine or Doctor of Osteopathy degree from an accredited medical school. Graduates of foreign medical schools must be certified by the Education Commission for Foreign Medical Graduates. Candidates for Civil Service or U.S. Commissioned Corps must be U.S. citizens. Permanent U.S. residents may apply for staff fellowship appointments.
Salary: Civil Service Salary GS-14, $81,905 to $102,965, plus a physician comparability allowance up to $24,000 (depending on years of experience) and an excellent benefits package. This is a term appointment (2 years), with the possibility of conversion to a permanent appointment.
How to apply: Submit curriculum vitae with cover letter indicating that you are applying under source code 102012 to:
Food and Drug Administration
Center for Drug Evaluation and Research
ATTN: Recruitment Team
7520 Standish Place, MPN1, Room 229, HFD-10
Rockville, MD 20855
Changes approved for Sustiva
The FDA approved on Feb. 1 a new formulation of Sustiva (efavirenz), a non-nucleoside reverse transcriptase inhibitor, for the treatment of HIV infection. Sustiva will now be available as a 600 mg tablet to be taken once daily in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors. Sustiva will continue to be available in the 50 mg, 100 mg, and 200 mg capsules in addition to the new 600 mg tablet.
In addition, the Sustiva label was revised to include new statements in the "dosage and administration" section. The revised statements are shown in italics below.
"Adults: The recommended dosage of SUSTIVA is 600 mg orally, once daily, in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs). It is recommended that SUSTIVA be taken on an empty stomach, preferably at bedtime. The increased efavirenz concentrations observed following administration of SUSTIVA with food may lead to an increase in frequency of adverse events. Dosing at bedtime may improve the tolerability of nervous system symptoms."
In addition, the "Clinical Pharmacology" and "Precautions" sections have been updated to include drug interaction information on Sustiva with the following medications: St. John’s wort, lorazepam, methadone, cetirizine, and rifabutin. The "Adverse Reaction" section was also revised to update the incidences of adverse events and laboratory abnormalities seen in clinical trials.
The revised label is in PDF format at this web site: www.fda.gov/cder/foi/label/2002/21360lbl.pdf
Shortage of Cytovene IV
MedWatch, the FDA Safety Information and Adverse Event Reporting Program, has advised health care professionals of a critical shortage of Cytovene-IV, indicated for the treatment or prevention of cytomegalovirus disease.
This shortage in supply is expected to last through the second quarter of 2002. Roche Laboratories is urging physicians to explore alternative treatment therapies or management strategies for their patients. This temporary situation affects only the IV formulation of Cytovene and not the oral formulation of Cytovene (ganciclovir capsules). This MedWatch Safety Alert is available at www.fda.gov/medwatch/SAFETY/2002/safety02.htm#cytove, including a link to a copy of the letter from Roche Laboratories.
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