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
FDA Policy/General
A Science exclusive investigative report says that by several measures, FDA compliance and enforcement actions have “plummeted” under the Trump administration. The agency’s Warning Letters have fallen by one-third, the report says, with FDA records showing 1,033 Warning Letters issued from President Trump’s inauguration through 5/
Devices
Civil and criminal penalties in cases involving an ACell medical device deserve further study by other device companies, according to attorneys Anne Walsh and Adrienne Lenz (Hyman, Phelps & McNamara). In a blog post for their firm’s FDA Law Blog, the two first discuss two whistleblower cases alleging that
Drugs
FDA says it has issued Warning Letters to three repackers of active pharmaceutical ingredients (APIs) for significant violations of current good manufacturing practice (CGMP) requirements. An agency news release says the letters went to B&B Pharmaceuticals, Inc. and Asclemed USA, Inc., doing business as Enovachem and Spectrum Laboratory
Drugs
FDA has issued an “immediate effect” guidance, Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients with Tetrahydrobiopterin (BH4) Deficiency, giving the conditions under which the agency does not generally intend to take regulatory action against a licensed pharmacist in a state-licensed pharmacy or
Drugs
FDA has published a draft guidance, Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products—Content and Format, to assist applicants in writing the Drug Abuse and Dependence section of labeling, as described in the regulations for the content and format of labeling for human
Drugs
FDA has published a draft guidance, Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format, with recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drug and biological
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.” The document focuses on drug development and trial design issues specific to the treatment of EB, including FDA’s current thinking on clinical trial endpoint considerations. To view the
Drugs
Fresenius Kabi USA has recalled two lots of fluorouracil injection, USP 5g/100ml (50mg/ml), 100ml fill in 100ml vials, due to the potential for them to contain glass particulates. “Products containing glass particulate should not be administered intravenously due to the potential for life-threatening consequences,” a recall notice
Devices
Edwards LifeSciences has recalled its IntraClude Intra-Aortic Occlusion Device due to balloon rupture risks during use, which could add time to the procedure and compromise patient safety. The balloon bursting “may cause serious adverse health consequences related to increased time the patient is on cardiopulmonary bypass, including neurological damage,
FDA Policy/General
Federal Register notice: FDA has issued a final rule to amend its regulations on internal agency supervisory review of certain decisions related to devices regulated by CDRH. The final rule codifies the procedures and timeframes for supervisory review of significant decisions pertaining to devices within CDRH. FDA is also finalizing
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on CDRH’s Device Good Manufacturing Practice Advisory Committee notify it in writing. FDA is also requesting nominations for a nonvoting industry representative to fill an upcoming
Devices
Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) have written to FDA acting commissioner Ned Sharpless expressing their opposition to the CDRH “progressive approval for devices” program in the FDA FY 2020 budget that appears to expand the agency’s “conditional approval” pathway for animal drugs to human
Devices
FDA has issued two guidances relating to the CDRH appeals process. The first, Center for Devices and RadiologicalHealth (CDRH) Appeals Processes, describes processes available to outside stakeholders to request additional review of decisions or actions by CDRH staff. The document notes that individuals outside FDA who disagree with a CDRH