Drugs
The HHS Office of Inspector General (OIG) says progress has been made in decreasing opioid use in Medicare Part D and increasing use of medication-assisted treatment for opioid use disorder. The OIG report says it is “imperative for HHS, including the Centers for Medicare and Medicaid Services, to continue
Drugs
U.S. WorldMeds, which holds an NDA for Apokyn (apomorphine hydrochloride injection) indicated for acute, intermittent treatment of some aspects of Parkinson’s disease, says FDA should require that any ANDA for a generic version of Apokyn seek approval of both its drug and device constituent parts. The company says
Devices
FDA has cleared a Biotronik 510(k) for the Biomonitor III injectable cardiac monitor. The device is designed to document suspected arrhythmia or unexplained syncope with increased clarity, enabling fast diagnosis and appropriate treatment, the company says. Biomonitor III is 60% smaller than its predecessor and comes “pre-loaded in
Drugs
Four K&L Gates attorneys dissect two Justice Department policy statements and their impact on healthcare companies and their law firms in an online blog post. The attorneys first examine a 1/2018 memo issued by Civil Fraud Division director Michael Granston to determine what has happened over the
Drugs
FDA has released the FDA-483 issued following a 6/13-6/21 inspection at the Dr. Reddy’s drug manufacturing facility in Andhra Pradesh, India. Specific inspection observations were: * failing to establish acceptance activities prior to performance of validation activities; and * failing to correctly translate device design into production
Devices
A 4/3-4/4 FDA inspection at Clinicon Corp., Oceanside, CA, found Quality System Regulation violations in the firm’s work as a manufacturer (specification developer) of the SureProbe Class 2 sterile, single-use, laser accessory probes, among other devices. A 6/20 Warning Letter says specific violations were:
Drugs
A CDER Manual of Policies and Procedures gives the policies and procedures for staff in the Office of New Drugs, Office of Generic Drugs, and other CDER offices when implementing the law on requirements for safety labeling changes for approved drugs under the FDA Amendments Act of 2007 (FDAAA). The
Drugs
The Tufts Center for the Study of Drug Development says rare disease drug development is one of the most active and fastest growing areas in drug research and development, with nearly one-third of all products in the global R&D pipeline targeting treatments for rare disease indications. But
Drugs
A 10/31-12/18/18 FDA inspection at U.S. Pharmaceuticals, Belleville, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 6/6 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 11 NDAs from multiple applicants because the products are no longer marketed and the NDA holders requested that their approval be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of DHL Laboratories’ NDA for dextrose 5% injection in plastic containers, 5 g/100 mL, because the company has repeatedly failed to file required annual reports for the NDA. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available an immediately in effect guidance entitled “Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency.” The document describes FDA’s policy concerning the conditions under which the agency does not generally intend to take
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 31 Apotex ANDAs after the company requested that they be withdrawn due to FDA inspection concerns. After the drugs were approved, FDA says it became aware of concerns involving material manufactured at two Apotex facilities, at least one of which was named
Drugs
FDA has issued a guidance, Risk Evaluation and Mitigation Strategies: Modifications and Revisions, with information on how the agency defines the types of changes to approved risk evaluation and mitigation strategies (REMS), and how it will process submissions from application holders for changes to REMS. The document specifically provides information
Drugs
FDA has accepted for review six Merck supplemental BLAs to update the dosing frequency for Keytruda (pembrolizumab) to include an every-six-weeks option. Merck says it is seeking approval of a 400 mg every-six-weeks dose infused over 30 minutes for indications in melanoma, classical Hodgkin lymphoma, primary
Drugs
FDA has released the FDA-483 issued following a 5/27-6/4 inspection at Indoco Remedies, Vasco Da Gama, Goa, India. The four specific inspection observations were: * determinations of conformance to appropriate written specifications for acceptance are deficient for drug products; * investigations of a failure of a batch or
Drugs
A 7/23-8/30/18 FDA inspection at the Akorn drug manufacturing facility in Somerset, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals that were similar to those found in inspections at other Akorn facilities. A just-released 6/13 Warning Letter says
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Akorn, Lake Forest, IL (6/13): FDA inspected the firm 8/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly investigate any
Drugs
A 2/4-2/9 FDA inspection at the Aurobindo Pharma drug manufacturing facility in Ranasathalam (Mandal), India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 6/20 Warning Letter says specific deviations were: * failing to extend investigations to other batches that
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for the notices that published in the Federal Register of 4/15 and 4/28 regarding issues related to using product identifiers for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to
FDA Policy/General
Federal Register notice: FDA is correcting a 9/5/2017 notice entitled “Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry.” The document was published with the incorrect docket number, and the corrected docket is No.
FDA Policy/General
Federal Register notice: FDA has determined that U.S. Pharmaceutical Holdings’ Claforan (cefotaxime sodium) for injection, 500 mg/vial, 1 g/vial, 2 g/vial and 10 g/vial, was not withdrawn from sale for reasons of safety or effectiveness. The determination means that FDA will not begin procedures to