Drugs
Durect has submitted a detailed reply to an FDA 2014 complete response letter for Posimir (bupivacaine extended-release solution), a post-operative pain relief depot product that uses the company’s Saber technology. The product is designed to be administered directly into a surgical site to deliver bupivacaine for up
Drugs
Members of the congressional Problem Solvers Caucus, 23 Democrats and 23 Republicans from both the House and the Senate, have released a list of seven principles for supporting prescription drug pricing legislation. A media statement from Sens. Susan Collins (R-ME) and Joe Manchin (D-WV) said legislation to address
Drugs
FDA has expanded the approval of Regeneron’s Dupixent (dupilumab) for use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. CRSwNP can be a debilitating condition, with many patients opting for systemic steroids or nasal surgery. The condition alos often
Drugs
FDA will receive feedback for 60 days on its Clinical Data Summary Report pilot program that is part of an effort to increase the transparency of the clinical data used in the regulatory decision-making process. A Federal Register notice says the agency also wants public feedback on a new
Drugs
Federal Register notice: FDA is seeking comments on an information collection extension related to a guidance on “Administrative Procedures for Clinical Laboratory Improvement Amendments (CLIA) Categorization — 42 CFR 493.17 (OMB Control Number 0910-0607)." The guidance describes procedures FDA uses to assign the complexity category to a device,
Drugs
A bipartisan group of House lawmakers has introduced legislation to make more over-the-counter (OTC) medications available to patients. The Over-the-Counter Monograph Safety, Innovation, and Reform Act was spearheaded by Reps. Diana DeGette (D-CO), Bob Latta (R-OH), Debbie Dingell (D-MI) and Brett Guthrie (R-
Drugs
A 1/28-2/1 FDA inspection at Rxhomeo Private Limited, Hyderabad, Telangana, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 6/13 Warning Letter says the violations were: * failing to test samples of each component for identity and conformity with all appropriate
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.
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
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
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.
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
Drugs
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 paper copy and
Drugs
Infusion Options has recalled all lots of its sterile products due to a lack of sterility assurance. “Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death,” a recall notice says. To date, the company says it has not