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FDA has published a draft guidance, Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products—Content and Format, to assist applicants in writing the Drug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FDA has published a draft guidance, Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and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
FDA Policy/General
Federal Register notice: FDA has announced a 9/10 Patient Engagement Advisory Committee meeting to discuss and make recommendations on “Cybersecurity in Medical Devices: Communication That Empowers Patients.” Recommendations provided by the committee will address which factors should be considered by FDA and industry when communicating cybersecurity risks to patients
Drugs
Under a 2017 CDER Manual of Policies and Procedures (MAPP), Prioritization of the Review of Original Abbreviated New Drug Applications (ANDAs), Amendments, and Supplements, ANDA submissions for drug products indicated for the emergency treatment of known or suspected opioid overdose are eligible for priority review. FDA says that based on
Drugs
A 7/6 New York Times editorial board opinion piece urges the Trump Administration to curb drug price increases the way Europe does – “by tying a drug’s price to its actual value.” It says HHS should evaluate and rank medications based on their cost effectiveness. The board notes that
Drugs
On the eve a rule was to go into effect requiring drug pricing information in direct-to-consumer ads, the Washington, DC federal district court ruled 7/8 that HHS lacks the statutory authority under the Social Security Act to mandate such disclosures. The 6/14 complaint from Merck, Eli
FDA Policy/General
Guide on Epidermolysis Bullosa Drug Development Federal Register notice: FDA makes available a final guidance entitled “Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.” 07/08/2019 Final Rule on CDRH Supervisory Review of Decisions Federal Register notice: FDA issues a final rule to amend its regulations on
FDA Policy/General
Sanofi and Google’s life sciences firm Verily say they will invest $500 million in a diabetes joint venture called Onduo that is intended to develop comprehensive solutions that combine devices, software, medicine, and professional care for disease management. The enterprise, which is based in Kendall Square in Cambridge, MA,
FDA Policy/General
DEVICES FDA has cleared an Integra LifeSciences Holdings 510(k) for its Integra Expandable Interbody System for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease. The device is intended for use with autogenous bone graft and supplemental fixation, and
Drugs
FDA has posted 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 trial endpoints. The agency notes that there is not yet sufficient
FDA Policy/General
Federal Register notice: FDA has announced a 7/26 public workshop entitled “Endpoints for Drug Development in Heart Failure” which is intended to focus on endpoints related to symptoms and physical function. In addition, there will be discussion of the need to assess mortality effects of drugs under development for