Drugs
Pharmaceutical Manufacturing Research Services (PMRS) has filed a lawsuit against FDA in eastern PA federal court seeking an order to compel the agency to provide a hearing on its decision not to approve the company’s NDA for oxycodone hydrochloride immediate-release oral capsules (see earlier story). In the complaint,
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” The agency says voluntary consensus standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, and facilitate market entry for safe and effective medical products. To
Devices
FDA has issued a safety alert on Alcon’s CyPass Micro-Stent, a small tube with tiny holes that is surgically implanted in the eye, due to its risk of eye damage. The device is used to drain fluid that causes high eye pressure and vision loss in people with
Devices
FDA says it is issuing a comprehensive plan to streamline agency review of medical device premarket submissions that have already undergone a review by qualified expert third parties. The plan sets a goal of having at least 85% of Third Party (3P) Review Program submissions proceed without substantive FDA re-
Drugs
FDA has approved AstraZeneca Pharmaceuticals’ Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for treating adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is a CD22-directed cytotoxin and is the
FDA Policy/General
Federal Register proposed rule: FDA is proposing to amend current regulations to incorporate changes made to the Freedom of Information Act (FOIA) by the Openness Promotes Effectiveness in our National Government Act of 2007 and the FOIA Improvement Act of 2016. Additionally, the proposed rule would update the current regulations
FDA Policy/General
Federal Register notice: FDA has announced a 10/22 public advisory committee meeting of its Science Board. The panel will hear a response from CVM on recommendations made by Board’s 2017 review of CVM’s National Antibiotic Resistance Monitoring System program. The Science Board will also discuss potential hazards
Drugs
Pharm D Solutions has recalled all sterile compounded drug products within expiry due to concerns that practices at the pharmacy have the potential to pose a contamination risk to products that are intended to be sterile. The decision to recall the products followed a routine inspection of the pharmacy by
FDA Policy/General
Federal Register proposed rule: FDA is proposing to amend requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. If finalized, the rule would reduce the number of required copies in electronic format and make more
Drugs
FDA has approved a Staar Surgical PMA supplement for the Visian Toric Implantable Collamer Lens (ICL) for the correction of myopia with astigmatism. The ICL will be available in both spherical and toric designs. The device is indicated for use in patients 21-45 years of age to correct myopic
Drugs
FDA says its latest testing of products with the active pharmaceutical ingredient (API) valsartan shows an additional unexpected impurity in three lots of Torrent Pharmaceuticals’ recalled products. An agency news release says that the second impurity, N-Nitrosodiethylamine (NDEA), is a known animal and suspected human carcinogen. The release also
Devices
FDA commissioner Scott Gottlieb says the agency is working on a new framework for appropriate regulation of diagnostics so that doctors and patients can get more of the information they need to pursue the right treatment at the right time and for the right patient. In a 9/13 speech
Drugs
FDA has released the FDA-483 issued following an 11/13-11/17/17 inspection at Yuki Gosei Kogyo, a Fukushima, Japan, active pharmaceutical ingredient (API) manufacturer. The document contains nine specific inspection observations: * laboratory control procedures are not followed; * records associated with drug substance production and within the retention
Devices
FDA has issued a draft guidance, Recognition and Withdrawal of Voluntary Consensus Standards, and a final guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, and will hold a 10/25 Webinar on the final guidance. The draft document was developed to provide guidance about the
Drugs
A FDA-483 issued following a 4/23-4/27 and 4/30-5/1 inspection at Cook Pharmica, Bloomington, IN, has five inspection observations. They are: * there is an unacceptably high number of mold recoveries in the classified rooms for manufacture of a redacted bulk drug substance; * written procedures
Drugs
FDA has released the FDA-483 issued following a 7/23-7/27 inspection at Unichem Laboratories, Pithampur, Dhar, India. Specific observations at the drug manufacturing firm were: * cleaning procedures are not validated; * test procedures are not scientifically sound and appropriate to ensure that raw materials, intermediates, APIs, and labels
Drugs
FDA has released additional draft and revised draft product-specific drug guidances. A Federal Register notice to be published 9/14 says the guidances provide product-specific recommendations on, among other things, the design of bioequivalence studies to support ANDAs. Comments on the drafts will be accepted for 60 days.
Devices
Attorneys Suzan Onel and Jacqueline Chan (Kleinfeld, Kaplan and Becker) say that 2018 has brought a “flood of guidance documents FDA has issued related to medical devices.” In an alert, the attorneys highlight some of the most notable guidance documents issued between 1/1 and 8/30 as they relate
Devices
FDA is proposing to amend requirements for medical device premarket submissions to remove paper and multiple copies and replace them with a requirement for a single electronic format submission. A Federal Register notice to be published 9/13 says the proposal, if finalized, would improve the agency’s premarket submission
FDA Policy/General
FDA says it wants to change its public information regulations to incorporate Freedom of Information Act (FOIA) changes from the Openness Promotes Effectiveness in Our National Government Act of 2007 and the FOIA Improvement Act of 2016. A Federal Register notice to be published 9/13 says the proposal also
Devices
FDA has awarded five grants totaling up to $6 million per year for the next five years to pediatric device consortia across the country to provide advice and support services to innovators of children’s medical devices. An agency news statement says the program “aims to enhance the development, production,
Drugs
FDA has released an FDA-483 issued following an 8/27-8/31 inspection at the Sun Pharmaceutical Industries drug manufacturing facility in Halol, Gujarat, India. Specific observations listed in the document were: * laboratory controls do not include establishment of scientifically sound and appropriate test procedures designed to assure that