FDA Policy/General
Federal Register Notice: FDA seeks comments on information collection requirements for postmarket surveillance of medical devices. Comments should be submitted by 6/27. To view this notice, click here.
FDA Policy/General
Federal Register Final rule: FDA published a document in the 4/18 Federal Register amending the animal drug regulations to reflect application-related actions for NADAs and ANADAs during January and February. That rule included two amendatory instructions that cited incorrect sections of 21 CFR part 524: “Ophthalmic and Topical
Drugs
Rep. Sean Maloney (D-NY) has introduced the Opioid Review Modernization Act of 2016 (H.R. 4976) to require FDA to seek advisory committee recommendations before approving opioids without abuse-deterrent properties. The bill also would create a strategy for educating doctors on the potential harms in overprescribing opioids. “No
Drugs
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says that the current legal/enforcement situation regarding off-label promotion of drugs and medical devices has little to commend it. Writing in an online Update, Shapiro says that the status quo “does not respect the First Amendment rights of device and drug
Drugs
Pfizer subsidiary Wyeth has agreed to settle allegations that between 2001 and 2006 it knowingly underpaid rebates owed under the Medicaid Drug Rebate Program for the sales of Protonix oral and Protonix IV. Under the settlement, Wyeth will pay a total of $785 million to the federal government and individual
Devices
The Infectious Disease Society of America, the American Society for Microbiology, and the Pan American Society for Clinical Virology say they are concerned that infectious diseases laboratory developed tests (LDTs), which they say have little evidence of providing unreliable results that lead to harmful patient care decisions, are not being
Drugs
FDA has extended by three months its review of a Dynavax Technologies BLA for Heplisav-B, an investigational vaccine for immunizing adults against Hepatitis B infection. Earlier this month, the company submitted FDA-requested individual trial data sets that had earlier been provided as integrated data. The agency has now
Drugs
Some 75 members of the House and Senate from both parties are expressing concern that FDA has loosened standards governing use of the abortion drug Mifeprex, also known as RU-486. In a 4/25 letter to FDA commissioner Robert Califf, the lawmakers say that the drug’s original approval
FDA Policy/General
Federal Register Notice: FDA is seeking public comments on requests for Clinical Laboratory Improvement Amendments of 1998 (CLIA) categorization of in vitro diagnostic tests when a premarket review is not needed. Comments should be submitted by 6/27. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA will hold a public meeting 9/27 on patient-focused drug development for patients who have received an organ transplant. The meeting is intended to allow the agency to obtain patient perspectives on the impact on daily life of receiving an organ transplant and patient views
FDA Policy/General
Federal Register Notice: FDA’s Office of Medical Products and Tobacco, CDER, Office of Medical Policy has modified its organizational structure. The Office of Medical Policy is headed by the Director, Office of Medical Policy and includes the following organizational units: Office of Medical Policy, Office of Prescription Drug Promotion,
Devices
At the 3/4 MDUFA 4 reauthorization meeting, industry representatives expressed concern that there was a large gap between an FDA proposal made at the meeting and the proposal that industry presented at an earlier meeting. Minutes from the 3/4 session indicate that the agency’s updated proposal package
Drugs
Chinese laboratories are producing and openly selling a new form of fentanyl to get around that country’s export laws and the fact that it is not yet on the U.S. government list of controlled substances. Stat News reports that furanyl fentanyl, which was blamed for the March overdose
Drugs
FDA says it believes that most issues identified by clozapine manufacturers when the drug’s REMS (Risk Evaluation and Mitigation Strategy) program was first implemented in 2015 have been resolved. In a post-market drug safety report, the agency says it is continuing to work with manufacturers to develop a
Drugs
FDA has issued Otsuka Pharmaceutical Co. and Proteus Digital Health a complete response letter for their Digital Medicine, a drug/device combination product that combines Otsuka’s Abilify (aripiprazole), an atypical antipsychotic, with the FDA-cleared Proteus ingestible sensor embedded in the tablet. The NDA was submitted as a system
Drugs
A 3/16-23/15 FDA inspection at Polydrug Laboratories, Mumbai, India, found significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients. A 4/14 Warning Letter says that specific deviations included: * failing to record and investigate all quality-related customer complaints according to
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Benedict S. Liao West Covina, CA (3/29). Inspected 8/11-9/29/15. Clinical investigation violations: The investigator failed to ensure that the investigation was conducted according to
Drugs
FDA has told Catalyst Pharmaceuticals that it will need positive results from an additional study of the company’s Firdapse (amifampridine phosphate) in patients with Lambert-Eaton myasthenic syndrome (LEMS) before the agency will accept Catalyst’s NDA for filing. FDA told the company that it is open to discuss
Devices
A 10/5-10/8/15 FDA inspection at DMP Ltd., Markopoulo, Greece, which manufactures dental impression materials and composite resins, found multiple Quality System Regulation violations, according to a just-released 3/4 Warning Letter. Specific violations listed on an FDA-483 included: * failing to establish and maintain procedures
Devices
FDA has cleared a Royal Philips 510(k) to market its computed tomography (CT) devices as a lung cancer screening center. The low-dose lung cancer screening indication pertains to the company’s 27 CT and PET/CT models, as well as integrated software and services, it says. To address
Drugs
FDA says it is evaluating the results of a Danish study that concluded there is a possible increased risk of miscarriage with use of oral fluconazone (Diflucan) for yeast infections. An agency safety communication says it also is reviewing additional data and will communicate final conclusions and recommendations when the
Drugs
FDA has released a list of Medication Guides including three new and 10 updated guides. New guides were released for Aciphex DR (rabeprazole sodium) delayed-release capsules; Pfizer’s Inflectra (infliximab), and Genentech’s Venclexta (venetoclax) tablets. Updated guides were released for Aciphex (rabeprazole sodium), Takeda’s Kazano (alogliptin benzoate