Drugs
Public Citizen says that unless an FDA proposed rule on institutional review board (IRB) waiver or alteration of informed consent for minimal risk clinical investigations is clarified, it could increase the risks to human subjects while undermining their right to informed consent before being enrolled in clinical trials. The group’
FDA Policy/General
With President Trump’s signature into law of a House-Senate final appropriations bill that ended the five-week government shutdown 2.16, FDA received a $269 million (9%) budget boost — the largest increase in several years. According to a House-Senate conferees’ statement, FDA will see $3.08 billion
Drugs
FDA is permitting marketing of Tandem Diabetes Care’s t:Slim X2 insulin pump with interoperable technology for delivering insulin under the skin for children and adults with diabetes. An agency announcement says this new type of pump, an alternate controller enabled (ACE) infusion pump, is the first interoperable pump,
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for Anacor Pharmaceuticals’ Eucrisa (crisaborole), indicated for topical treatment of mild to moderate atopic dermatitis in patients two years of age and older. The regulatory review period was determined to be 3,121 days, including 2,778 days that occurred
Drugs
Sen. Edward Markey (D-MA) and Rep. Diana DeGette (D-CO) have written to FDA commissioner Scott Gottlieb expressing their concern with agency approval of AcelRx’ Dsuvia (sufentanil sublingual tablets) that they say is 10 times more potent than fentanyl and 1,000 times more powerful than morphine. “While we
Drugs
In what many are calling a breakthrough treatment for depression, Janssen Pharmaceutical has moved one step closer to FDA approval after the agency’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee 2/12 jointly voted 14 to 2 to support Spravato (esketamine) nasal spray. The
Drugs
House Energy and Commerce Committee leaders have sent a letter to FDA commissioner Scott Gottlieb requesting a briefing on numerous recalls involving drugs manufactured overseas that may have been contaminated with trace amounts of known carcinogens, which could lead to a shortage of drugs to treat high blood pressure (see
Drugs
A 1/24-2/9/18 FDA inspection at Samson Pharmaceuticals’ drug manufacturing facility in Commerce, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 12/13/18 Warning Letter says the violations were: * failing to perform aseptic processing operations within specifically
Devices
FDA has sent LC Medical Concepts a 1/31-dated Warning Letter after a 10/2018 inspection of the firm’s Rochester, NY, medical device operations found GMP concerns with the manufacturing of negative pressure wound therapy kits. The agency cited the company for failing to adequately validate with a
Drugs
A 4/9-5/16/18 FDA inspection at the Akorn drug manufacturing facility in Decatur, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 1/4 Warning Letter says specific violations were: * failing to follow appropriate written procedures designed to prevent
Drugs
FDA has released the FDA-483 with 13 observations issued following an 8/6-8/14/18 inspection at Immunomedics, a Morris Plains, NJ, drug substance intermediate manufacturing facility. Specific observations were: * the quality unit lacks authority to investigate critical deviations of approved procedures, specifically involving a 2/2018 data
Devices
Attorney Adrienne Lenz (Hyman, Phelps & McNamara) says that while industry may feel that under the FDA 2/5 final guidance on least burdensome provisions it is continually being asked for more information, data, and studies to support their devices, “the final guidance, by way of sharing examples where FDA
Drugs
FDA has released a draft guidance, CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality, describing a proposed program to make public a comprehensive listing of informally recognized voluntary consensus standards related to pharmaceutical quality. “CDER is issuing this guidance to obtain public comments on
FDA Policy/General
Federal Register notice: FDA has announced the issuance of an Emergency Use Authorization (EUA) for a Chembio Diagnostic Systems in vitro diagnostic device for detecting Ebola virus in response to an Ebola virus outbreak in the Democratic Republic of the Congo. The EUA contains, among other things, conditions on the
Drugs
FDA has released the FDA-483 issued following a 1/17-1/25 inspection at Indoco Remedies Limited (Plant 1), a Goa, India, tablet manufacturer. The six inspection observations were: * failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for MSD Italia’s Zejula (niraparib), indicated for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The regulatory review period was
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Safety Labeling Changes — Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0734). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for Newron Pharmaceuticals’ Xadago (safinamide mesylate), indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes. The agency determined Xadago’s regulatory review period at 5,019 days, including 4,205 days that occurred
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Assessment of Combination Product Review Practices.” As part of the 2017 reauthorization of the Prescription Drug User Fee Act, FDA committed to contracting with an independent third party to assess current practices for combination drug product review,
Drugs
FDA commissioner Scott Gottlieb says the agency has issued its first Warning Letter under the Drug Supply Chain Security Act, citing McKesson Corp. for violations highlighted by a “concerning tampering incident that involved opioid medications. Other incidents involved medications for serious medical conditions including HIV, seizures, bipolar disorder, and high
FDA Policy/General
FDA Office of Chief Scientist critical path and regulatory science initiatives director Frank Weichold says that since 2012, the agency’s Centers for Regulatory Science and Innovation (CERSI) have grown from two to four Centers involving five universities and one nonprofit hospital. As of 12/2018, he says, the program
Drugs
Allergan says it “applauds FDA’s efforts to articulate thoughtful and science-driven guidelines” relating to development of biosimilar products. In a 2/11 comment letter on an FDA revised draft Q&As on biosimilar development and the Biologics Price Competition and Innovation Act, the company says the agency’