July 25th, 2014:
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] – Guidance for Industry and FDA Staff- “A guidance document titled, “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” has recently been posted. The FDA developed this document to provide guidance to industry and FDA staff about current review practices for premarket notification (510(k)) submissions.”
Clinical Investigator Training Course- “FDA’s Center for Drug Evaluation and Research/Office of Medical Policy and the Duke University Office of Continuing Medical Education are cosponsoring a 3-day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials.”
Revised Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications
Draft Guidances describing GDUFA performance metrics and associated webinars
FDA published notices in the Federal Register announcing the availability of two draft guidances for industry:
FDA approves GSK’s Flonase as an OTC treatment- “GlaxoSmithKline on Thursday announced that the Food and Drug Administration has approved Flonase Allergy Relief (fluticasone propionate 50 mcg spray), as an over-the-counter treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies.”
Philips’ mobile ultrasound scanner scores FDA clearance- “The FDA has cleared Philips Healthcare to market its Visiq system, a mobile ultrasound scanner designed to ease the way abdominal and obstetric imaging is performed.”
July 24th, 2014: District Court Enters Permanent Injunction Against New York Dietary Supplement Maker to Prevent Distribution of Adulterated Supplements.
“The Justice Department announced today that the U.S. District Court for the Eastern District of New York has entered a consent decree of permanent injunction against Applied Polymer Systems dba APS Pharmaco (APS) and its president, Nuka Reddy, all of Lindenhurst, New York, to prevent the distribution of adulterated dietary supplements.”
July 16th, 2014: (The U.S. Government Accountability Office “GAO” News)- Additional Federal Actions Could Help Address Unique Challenges of Educating Children in Nursing Homes. GAO-14-585, July 16.
“Children in nursing homes represent a relatively small group of children whose medically complex conditions often present unique educational challenges. Of the nearly 5,000 school-age children in nursing homes nationwide, about 40 percent needed a feeding tube for nutrition and one-third needed oxygen therapy to help them breathe, according to GAO’s analysis of 2012 data—the most recent data available—from the Department of Health and Human Services (HHS).”
July 11th, 2014: Recall- Hospira Lactated Ringer’s And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) – Mold Contamination
Hospira, Inc. announced it is initiating a voluntary nationwide user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09, Lot 35-118-JT, Expiry 1NOV2015 . This action is due to one confirmed customer report where particulate was identified within the solution of the primary container.
July 10th, 2014: CDER Small Business and Industry Assistance (CDER SBIA) Webinar on “ANDA Submissions – Prior Approval Supplements Under GDUFA”
Background: “On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law by the President of the United States of America. GDUFA was designed to speed the delivery of safe, effective, and high-quality generic drugs to the public. This program will bring greater predictability and timeliness to the review of generic drug applications. GDUFA is based on an agreement negotiated by FDA and representatives of the generic drug industry.”
On July 10th, FDA published two notices in the Federal Register announcing the availability of:
Drug Firm Annual Registration Status (updated) —Find out which drugs are currently registered on the FDA site by clicking this link.
FDA outlines expectations for human drug compounders, including registered outsourcing facilities —“On July 1, 2014 the U.S. Food and Drug Administration issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists.”
Guidance for Industry:
Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (PDF – 223KB) –“This interim guidance describes FDA’s expectations regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound human drugs and 22 register with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and 23 Cosmetic Act (FD&C Act).”
Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF – 85KB) —“This guidance announces FDA’s intention with regard to enforcement of section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 353a) to regulate entities that compound drugs, now that section 503A has been amended by Congress to remove the advertising and solicitation provisions that were held unconstitutional by the U.S. Supreme Court in 2002.”
MedWatch Safety Alert:
Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb: Recall – Particulate Matter—“Bristol-Myers Squibb Company issued a voluntary recall of six lots of Coumadin for Injection, 5 mg single-use vials in the U.S. Visible particulate matter was found in a small number of Coumadin for Injection unreleased samples. Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization. Allergic reactions to the foreign material could also occur.”
Postmarket Drug and Biologic Safety Evaluations (updated)—“This website provides summary information about ongoing and completed postmarket safety evaluations of adverse experience reports made to FDA for New Drug Applications (NDAs) and Biologics License Applications (BLAs).”
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