February 7, 2009Kidney Risk Spurs Warning on Bowel Cleansers Kidney Risk Spurs Warning on Bowel Cleansers
FDA requires new safety measures for products used as bowel cleansers before colon examinations. Source: www.fda.gov FDA Warns Bayer About Two Unapproved Aspirin Products FDA has sent warning letters to Bayer HealthCare regarding two over-the-counter products that combine aspirin with a dietary supplement into a single pill. Source: www.fda.gov Using Over-the-Counter Cough and Cold Products in Children FDA supports the voluntary actions of drug manufacturers to better inform consumers about the safe and effective use of over-the-counter cough and cold medicines in children. Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) See Web site for additional information. Source: www.fda.gov February 6, 2009BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics
BPCA/Pediatric Exclusivity Statistics (updated) Source: www.fda.gov Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Product Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Albuterol Metered Dose Inhalers and Levalbuterol Metered Dose Inhalers The transition from albuterol CFC MDIs to albuterol HFA MDIs is now complete and supplies of albuterol HFA and levalbuterol HFA MDIs continue to meet total market demand. Source: internet-dev Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act; Public Hearing, 12/12/2008; Presentations Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act; Public Hearing, 12/12/2008; Presentations Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules
See Web site for additional information Source: www.fda.gov Innohep (tinzaparin sodium injection) [UPDATE] Dear Healthcare Professional letter issued re: increased risk of death in elderly patients with renal insufficiency Source: www.fda.gov Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage Source: www.fda.gov Preventing Medical Errors: Drug Name Confusion Between Kuric and Carac The Institute for Safe Medication Practices (ISMP) recently reported on the potential for mix-ups between two topical creams: Kuric (ketoconazole) and Carac (fluorouracil). Kuric is used to treat fungal infections and seborrheic dermatitis. Carac ... Source: www.accessdata.fda.gov Patients Are Asking: New Labels for Non-prescription Cough and Cold Medications Most makers of nonprescription cough and cold medicines are voluntarily changing the labels on these products to say "do not use" for children under 4 years of age. New child resistant packaging and measuring devices are also being introduced. ... Source: www.accessdata.fda.gov February 5, 2009CDER Organization ChartsTainted Weight Loss Pills Flagged as Health Risks Tainted Weight Loss Pills Flagged as Health Risks
FDA has alerted consumers not to buy or use more than 25 weight-loss products. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Related information section for updated Letter from Mallinckrodt Source: www.fda.gov FDA Acts to Reduce Risk of Salmonella Infections Find out why pet turtles may be a health risk and how FDA is enforcing a ban on the small creatures. Source: www.fda.gov Some Medications and Driving Don't Mix Some prescription and over-the-counter (OTC) medicines can cause reactions that may make it unsafe to drive. Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated See information in Related Information section. Source: www.fda.gov Mexican Vanilla With Coumarin: No Bargain Mexican Vanilla With Coumarin: No Bargain
Beware of Mexican vanilla that contains coumarin, a toxic substance banned in the United States. Drug Shortages: Resolved Drug Shortages; Argatroban Injection See Related information section Drug Shortages: Current Drug Shortages; Argatroban Injection See Related information section Food Safety Tips for Healthy Holidays FDA gives consumers practical food safety tips to help prevent foodborne illness. Use Caution With Ayurvedic Products The presence of heavy metals in some Ayurvedic products makes them potentially harmful. Botulism Risk From Ungutted, Salt-Cured Alewives Fish Consumers should not eat this product because it may contain Clostridium botulinum toxin. February 4, 2009Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS)
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) (updated) Drug Shortages: Current Drug Shortages; Leucovorin See web site for additional information Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) 2009 PDA/FDA Joint Regulatory Conference, September 14-18, 2009, Renaissance Hotel, 999 9th Street NW, Washington, D.C. The PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) FDA Warns Consumers Against Dietary Supplement Containing Undeclared Drug The U.S. Food and Drug Administration is warning consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement and containing sibutramine. Sibutramine, a controlled substance with risks for abuse or addiction, is a potent drug that poses potential safety risks. Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) BPCA of 2007: List of Determinations including Written Request Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated) January First-Time Generic Drug Approvals Office of Generic Drugs: January First-Time Generic Drug Approvals FDA Issues Guidances for Industry to Improve the Safety of Food, Feed and Drugs FDA Issues Guidances for Industry to Improve the Safety of Food, Feed and Drugs
The U.S. Food and Drug Administration today issued three guidances designed to help ensure the safety of FDA-regulated products in the supply chain. Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Web site for additional information FDA Issues Early Communication about a Safety Review of Xigris The U.S. Food and Drug Administration today announced that it is working with the maker of Xigris (drotrecogin alfa activated), Eli Lilly and Company, to further evaluate the incidence of serious bleeding events and death in patients who receive Xigris, a drug used to treat severe sepsis (a blood stream infection). Guidance for Industry Guidance for Industry
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act February 3, 2009Adverse Event Reporting System (AERS) Statistics(updated) Adverse Event Reporting System (AERS) Statistics(updated)
Adverse Event Reporting System (AERS) Statistics (updated) Drugs Shortages: Resolved Drug Shortage Drugs@FDA Downloadable Data Files (updated) Pediatric Exclusivity Labeling Changes BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated) FDA Data Standards Manual CDER Data Standards Manual: Drug Nomenclature Monograph (updated) Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) FDA Announces Two Appointments FDA Announces Two Appointments
Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., today announced the appointments of Lou Valdez as associate commissioner for international programs, and of Lori Davis as chief information officer. FDA Obtains Injunction to Stop Production of Illegally Medicated Animal Feed The U.S. Food and Drug Administration announced today that the District Court for the Western District of Missouri entered a Consent Decree on Dec. 15, 2008, prohibiting Milbank Mills, an animal feed mill in Chillicothe, Mo., from manufacturing, processing, or distributing medicated animal feed. Milbank Mills and its officers Edward P. Milbank and Darrell L. Allen, face these restrictions until they comply with current Good Manufacturing Practice (cGMP) requirements for medicated animal feeds. FDA Warns Consumers About Tainted Weight Loss Pills The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk. FDA Prevents Two Dairies from Adulterating Animal Drugs and Food The U.S. Food and Drug Administration announced today that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene Handley, from adulterating new animal drugs and introducing adulterated food into commerce. Both companies are based in Clovis, N.M. Preventing Medical Errors: Drug Name Confusion Between Kuric and Carac The Institute for Safe Medication Practices (ISMP) recently reported on the potential for mix-ups between two topical creams: Kuric (ketoconazole) and Carac (fluorouracil). Kuric is used to treat fungal infections and seborrheic dermatitis. Carac ... FDA Approves Drug for Patients with Advanced Prostate Cancer The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer. Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer. Recalls and Safety Alerts: Recall of ReliOn Insulin Syringes Covidien, formerly Tyco Health Care, has recalled one lot of ReliOn disposable insulin syringes because of mislabeling. Some of the U-40 syringes in this lot were mistakenly labeled as U-100 syringes. Patients using U-100 insulin could experience a... Recalls and Safety Alerts: Serious Complications with Surgical Mesh for Gynecologic Surgery The FDA is alerting healthcare professionals about rare but serious complications associated with the surgical mesh used to treat pelvic organ prolapse and stress urinary incontinence. The mesh is usually placed transvaginally using minimally invasi... February 2, 2009Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products
Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Product BPCA of 2007: List of Determinations including Written Request Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated) Weight Loss Pills Products contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk. Drugs Shortages: Resolved Drug Shortage Drugs@FDA Downloadable Data Files (updated) BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) Guidance for Industry Animal Models — Essential Elements to Address Efficacy Under the Animal Rule Caution to Dog Owners About Chicken Jerky Products Caution to Dog Owners About Chicken Jerky Products
FDA continues to caution consumers about feeding dogs chicken jerky products. Weight Loss Pills Products contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk. Get Set for Winter Illness Season What can you do about colds and flu? FDA offers tips for prevention and treatment. FDA Announces Two Appointments FDA Announces Two Appointments
Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., today announced the appointments of Lou Valdez as associate commissioner for international programs, and of Lori Davis as chief information officer. Innohep (tinzaparin sodium injection) [UPDATE] Dear Healthcare Professional letter issued re: increased risk of death in elderly patients with renal insufficiency FDA Approves RiaSTAP for Treatment of Bleeding in Patients with Rare Genetic Defect The U.S. Food and Drug Administration today licensed RiaSTAP, an orphan drug for the treatment of bleeding in patients with a rare genetic defect known as congenital fibrinogen deficiency. Without treatment, these patients are at risk of potentially life-threatening bleeding. FDA Announces Class I Recall of Ophthalmic Surgical Device The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif. FDA Prevents Two Dairies from Adulterating Animal Drugs and Food The U.S. Food and Drug Administration announced today that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene Handley, from adulterating new animal drugs and introducing adulterated food into commerce. Both companies are based in Clovis, N.M. February 1, 2009FDA Issues Final Guidance on Regulating Genetically Engineered Animals FDA Issues Final Guidance on Regulating Genetically Engineered Animals
The U.S. Food and Drug Administration today issued a final guidance for industry on the regulation of genetically engineered (GE) animals under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act (FFDCA). The guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," clarifies the FDA's statutory and regulatory authority, and provides recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law. Preventing Medical Errors: Drug Name Confusion Between Kuric and Carac The Institute for Safe Medication Practices (ISMP) recently reported on the potential for mix-ups between two topical creams: Kuric (ketoconazole) and Carac (fluorouracil). Kuric is used to treat fungal infections and seborrheic dermatitis. Carac ... FDA Warns Consumers About Tainted Weight Loss Pills The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk. Hydromorphone HCl 2 mg Tablets Nationwide recall of a single lot due to potential for oversized tablets. FDA Launches Pilot Program To Improve the Safety of Drugs and Active Drug Ingredients Produced Outside the United States The U.S. Food and Drug Administration today announced the launch of a voluntary pilot program that would help promote the safety of drugs and active drug ingredients produced outside the United States. Preventing Medical Errors: More Mix-ups between Propylthiouracil and Purinethol The Institute for Safe Medication Practices (ISMP) is warning about mix-ups between the trade name of one drug and the generic name of another. Purinethol® (mercaptopurine), is the trade name of a potent antimetabolite used in oncology. Propylthiou... Weight Loss Pills Products contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk. FDA Announces Two Appointments Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., today announced the appointments of Lou Valdez as associate commissioner for international programs, and of Lori Davis as chief information officer. Get Set for Winter Illness Season Get Set for Winter Illness Season
What can you do about colds and flu? FDA offers tips for prevention and treatment. FDA Warns Consumers Against Dietary Supplement Containing Undeclared Drug he U.S. Food and Drug Administration is warning consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement and containing sibutramine. Sibutramine, a controlled substance with risks for abuse or addiction, is a potent drug that poses potential safety risks. FDA Obtains Injunction to Stop Production of Illegally Medicated Animal Feed The U.S. Food and Drug Administration announced today that the District Court for the Western District of Missouri entered a Consent Decree on Dec. 15, 2008, prohibiting Milbank Mills, an animal feed mill in Chillicothe, Mo., from manufacturing, processing, or distributing medicated animal feed. Milbank Mills and its officers Edward P. Milbank and Darrell L. Allen, face these restrictions until they comply with current Good Manufacturing Practice (cGMP) requirements for medicated animal feeds. Beware of Extortion Scam by FDA Impersonators As part of a fraudulent scheme to extort money, callers have falsely identified themselves as "FDA special agents" or other FDA officials. Using Over-the-Counter Cough and Cold Products in Children FDA supports the voluntary actions of drug manufacturers to better inform consumers about the safe and effective use of over-the-counter cough and cold medicines in children. Avoiding Drug Interactions Be careful about the three main types of interactions: drugs with food and beverages, drugs with dietary supplements, and drugs with other drugs. FDA Prevents Two Dairies from Adulterating Animal Drugs and Food The U.S. Food and Drug Administration announced today that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene Handley, from adulterating new animal drugs and introducing adulterated food into commerce. Both companies are based in Clovis, N.M. FDA Approves First Imaging Agent to Enhance Scans of Blood Flow The U.S. Food and Drug Administration today approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA, a minimally invasive test for examining blood vessels. Recalls and Melamine Contamination FDA has increased inspections and product testing in response to the melamine contamination problem that originated in Chinese dairy products. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated)
Updated letter on this current drug shortage Singulair (montelukast) Singulair (montelukast)
FDA provided updated information to its March 2008 Early Communication. FDA issues an Early Communication about an Ongoing Safety Review of clopidogrel bisulfate (marketed as Plavix) FDA issues an Early Communication about an Ongoing Safety Review of clopidogrel bisulfate (marketed as Plavix) Improper Use of Decorative Contacts May Haunt You Halloween is a good time to remind people that improper use of non-prescription decorative contact lenses may harm your vision Innohep (tinzaparin sodium injection) [UPDATE] Dear Healthcare Professional letter issued re: increased risk of death in elderly patients with renal insufficiency Guidance for Industry Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Product Venom HYPERDRIVE 3.0 Product marketed as dietary supplement contains undeclared sibutramine, a controlled substance with risks for abuse or addiction, and can substantially increase blood pressure and heart rate. |
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