Drugs
FDA has clarified for small businesses when “research” versus “commercial” should be selected on FDA-1571 and thus when electronic common technical document requirements would apply for an IND application. In a podcast, CDER Office of New Drugs team leader Paul Phillips says a commercial IND is one for which
Drugs
FDA has issued a Warning Letter to Akorn, Inc., relating to a 2018 inspection at its Somerset, NJ, drug manufacturing facility. The company says it “will respond to the FDA letter within the required 15 working days” and “is committed to resolving the Warning Letter in a comprehensive and effective
Drugs
FDA has issued Acer Therapeutics a complete response letter on its NDA for Edsivo (celiprolol) for treating vascular Ehlers-Danlos syndrome (vEDS). The agency letter says it will be necessary to conduct an adequate and well-controlled trial to “determine whether celiprolol reduces the risk of clinical events in patients
Drugs
Bipartisan leaders of the House Energy and Commerce Committee are asking for information from FDA on two agency actions relating to opioids. In a 6/25 letter to agency acting commissioner Ned Sharpless, the legislators raise questions about (1) the agency’s management of safeguards against high-risk patients being
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. International Hospital Products, Littleton, CO (5/29): FDA inspected the firm 3/15-19 and cited GMP violations with its Baker Jejunostomy and intestinal tubes used for bowel decompression.
Drugs
FDA has sent Daiichi Sankyo a complete response letter on its NDA for quizartinib for treating adults with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Quizartinib, an oral selective Type II FLT3 inhibitor, was approved earlier this month by Japan under the brand name Vanflyta for the same indication.
Devices
A 3/15-3/19 FDA inspection at International Hospital Products, Littleton, CO, found Quality System Regulation violations in the firm’s work as a manufacturer (specification developer) of Class 2 Baker Jejunostomy and intestinal tubes used for bowel decompression. A 5/29 Warning Letter says specific violations were: * failing
Biologics
The Healthcare Distribution Alliance says it commends FDA for issuing a draft guidance on initiating voluntary recalls and the clarity and assistance it offers to recalling firms and their trading partners. It also says the draft is not aligned with Drug Supply Chain Security Act requirements and explains its detailed
Drugs
FDA has approved an Amag Pharmaceuticals NDA for Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. An FDA news release says that HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Reporting Associated With New Animal Drug Applications (NADA) and Veterinary Master Files — 21 CFR 514.1, 514.4, 514.5, 514.6, 514.8, 514.11, and 558.5” (OMB Control Number 0910-0032). To view the
FDA Policy/General
Federal Register notice: FDA has published a final guidance entitled “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs.” The document describes various types of promotional material, regulatory submissions, and specific recommendations for the content and format for such submissions in
FDA Policy/General
Federal Register notice: FDA has announced a 9/13 Allergenic Products Advisory Committee meeting. The panel is scheduled to discuss and make recommendations on the safety and efficacy of Peanut [Arachis hypogaea] Allergen Powder manufactured by Aimmune Therapeutics, indicated for reducing the risk of anaphylaxis after accidental exposure to peanuts
Drugs
U.S. Representatives Jan Schakowsky (D-IL), Rosa DeLauro (D-CT) , Angie Craig (D-MN), Lloyd Doggett (D-TX), Raja Krishnamoorthi (D-IL), and Andy Levin (D-MI) have introduced HR 3379, the Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act, that would reduce the exclusivity period for
Drugs
FDA has lifted a partial clinical hold on an AbbVie/Genentech Phase 3 CANOVA (M13-494) trial evaluating venetoclax for the investigational treatment of relapsed/refractory multiple myeloma. The trial is evaluating venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma
Drugs
FDA issued a five-page Form 483 after it inspected a Sun Pharmaceutical Industries Gujarat, India manufacturing facility 6/3-11. According to the document, FDA investigators cited the firm for not following procedures that are designed to prevent microbiological contamination of drug products. For example, the form said that
Devices
A 6/19-20 meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee unanimously agreed that data show a mortality signal associated with paclitaxel-coated products (e.g., balloons and stents) used to treat peripheral arterial disease in the femoropopliteal arteries. However, panel members were uncertain
Drugs
FDA has updated its “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic.” The list identifies NDAs for drug products that are not protected by patents or exclusivities at the time of the update, and for which the agency FDA has not approved an ANDA referencing the NDA.
FDA Policy/General
Priority Review Voucher Awarded to AveXis Federal Register notice: FDA announces that it issued a priority review voucher to AveXis for gaining approval for its rare pediatric disease product Zolgensma (onasemnogene abeparvovec-xioi). 06/21/2019 Panel to Review Gilead sNDA for Descovy Federal Register notice: FDA announces an 8/
FDA Policy/General
DEVICES FDA has cleared an Advanced Cooling Therapy 510(k) for the Esophageal Cooling Device for modulating and controlling patient temperature when clinically indicated through a single use, fully-enclosed triple lumen system that is inserted into the esophagus. “Two lumens attach to existing temperature modulation equipment while a third
FDA Policy/General
Federal Register notice: FDA has announced that it issued a priority review voucher to AveXis for its rare pediatric disease product Zolgensma (onasemnogene abeparvovec-xioi), indicated for treating pediatric patients less than two years of age with spinal muscular atrophy with biallelic mutations in the survival motor neuron 1 gene.
FDA Policy/General
FDA acting commissioner Ned Sharpless told the Washington Post 6/19 (see transcript) that he would like to be nominated by President Trump as the next agency commissioner. “The FDA is a wonderful, marvelous place,” he said. “The people are these cutting-edge scientists with this great passion and sense
Drugs
FDA has expanded the indication of Vertex Pharmaceuticals’ Symdeko (tezacaftor/ivacaftor) tablets for treating pediatric patients aged six years and older with cystic fibrosis who have certain genetic mutations. Last year, Symdeko was approved to treat patients ages 12 and older who had the same specific genetic mutations. Cystic fibrosis