Drugs
FDA has accepted a Sarepta Therapeutics NDA seeking accelerated approval for golodirsen (SRP-4053), indicated for treating those individuals with Duchenne muscular dystrophy who have genetic mutations subject to skipping exon 53 of the dystrophin gene. The agency has set an 8/19 user fee review action target date. The
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.” The proposed program would make public a comprehensive listing of informally recognized standards in order to help promote innovation in pharmaceutical development and manufacturing and
FDA Policy/General
Federal Register notice: FDA has announced the withdrawal of a Takeda Pharmaceuticals NDA for Omontys (peginesatide) injection, indicated for treating anemia due to chronic kidney disease in adult patients on dialysis. The drug was approved in 2012, but in 2013 all lots were voluntarily recalled and marketing was suspended due
Drugs
A 3/26-4/4/18 FDA inspection at Vitalab Pharmacy, Phoenix, AZ, found “serious deficiencies in your practices for producing sterile drug products, which put patients at risk,” according to a just-released 1/10 Warning Letter. The letter acknowledges that on 4/4/18, upon receipt of an
Drugs
CDER is soliciting applications for an Established Conditions pilot program to propose explicit established conditions (ECs) as part of an NDA, ANDA, BLA, or prior approval supplement to any of those three. A Federal Register notice says the concept of ECs was first described in a 5/2015 FDA draft
Drugs
FDA has issued Motif Bio a complete response letter on its NDA for iclaprim for treating acute bacterial skin and skin structure infections. The letter indicates that additional data are needed to further evaluate the risk for liver toxicity before the NDA may be approved, according to the company. Motif
Devices
In a 2/13 Warning Letter, FDA says Dr. Mark Berman, Beverly Hills, CA, has been manufacturing a medical device known as the Pocket Protector, an expanded-polytetrafluoroethylene pouch used to line the inside of a breast pocket during breast augmentation procedures. The letter cites many of the marketing claims
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