FDA Policy/General
FDA Warning Letters issued to medical product makers are significantly down in 2017, and several agency watchers are worried that president Donald Trump’s anti-regulation stance could be behind the drop. Letters posted on FDA’s Web site show a 30% decline from the eight-year average of the
FDA Policy/General
Federal Register notice: FDA has announced a 10/12 Cellular, Tissue, and Gene Therapies Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on the safety and effectiveness of a Spark Therapeutics BLA for voretigene neparvovec, indicated for treating patients with vision loss due to confirmed biallelic
FDA Policy/General
FDA has put in place new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine. While stem cell research and regenerative medicine hold much promise, some clinics and “unscrupulous actors” are “exploiting the uncertainty” by making “deceptive, and sometimes corrupt, assurances to patients
FDA Policy/General
MilliporeSigma has entered into an agreement to acquire Natrix Separations, an Ontario, Canada-based provider of hydrogel membrane products for single-use chromatography, for an indisclosed amount. The acquisition is intended to complement MilliporeSigma’s efforts to drive next-generation bioprocessing, ultimately enabling faster, more efficient technology for customers. CSL
FDA Policy/General
Draft Guide on Drug Supply Trading Partners Federal Register notice: FDA makes available a draft guidance entitled “Identifying Trading Partners Under the Drug Supply Chain Security Act.” 08/25/2017 Guidance on Oncology Drugs for Companion Animals Federal Register notice: FDA makes available a guidance for industry #237 entitled “Oncology
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Identifying Trading Partners Under the Drug Supply Chain Security Act.” The document is intended to assist industry and state and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug
FDA Policy/General
Federal Register notice: FDA has made available a guidance for industry #237 entitled “Oncology Drugs for Companion Animals.” The document provides recommendations for sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses), discusses the contents of a new animal drug application for certain
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health — OMB Control Number 0910–0769.” The collection requests information voluntarily submitted to CDRH on actual or potential health risk concerns about a medical device
FDA Policy/General
FDA has issued a guidance, Oncology Drugs for Companion Animals, with recommendations for sponsors of investigational oncology drugs for use in companion animals such as cats, dogs, and horses. The document discusses the contents of the target animal safety, effectiveness, and labeling sections of a new animal drug application. It
FDA Policy/General
FDA has issued a guidance, Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD), to address the nature and types of data that can be useful in determining a toxicological acute reference dose for residues of veterinary
FDA Policy/General
FDA Deputy Commissioner and Office of Medical Products and Tobacco director Rachel Sherman has accepted the position principal deputy commissioner. In this role, Sherman will oversee all medical programs and initiatives that are cross-cutting and clinical, scientific, and/or regulatory in nature, according to FDA commissioner Scott Gottlieb. “She
FDA Policy/General
Federal Register notice: FDA is seeking comment on an information collection entitled “Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded — 21 CFR 330.14.” FDA regulations at 21 CFR 330.14 establish additional criteria and procedures for classifying
FDA Policy/General
Federal Register notice: FDA has announced a 9/28 Peripheral and Central Nervous System Drugs Advisory Committee meeting. Panel members will discuss and vote on a PTC Therapeutics NDA for ataluren for oral suspension, indicated for treating patients with dystrophinopathy due to a nonsense mutation in the dystrophin gene. To
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Medical Devices; Exception From General Requirements for Informed Consent.” In 2006, FDA issued an interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use
FDA Policy/General
Federal Register notice: FDA has announced a 9/11-12 Pediatric Advisory Committee meeting in Rockville, MD. Panel members are scheduled to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has established a public docket to assist with its development of recommendations on the communication of risk information in direct-to-consumer broadcast advertisements for prescription drugs and biologics. To view the notice, click here.
FDA Policy/General
Federal Register final rule technical amendment: FDA is amending the Medical Device Classification Procedures regulation to reflect a change in address for CDRH. The mailing address is revised as follows: Center for Devices and Radiological Health, Regulations Staff, Document Mail Center – WO66–G609, 10903 New Hampshire Ave., Silver Spring, MD
FDA Policy/General
Federal Register notice: FDA has determined for patent restoration purposes the regulatory review period for Acrux DDS Pty. Ltd.’s Recuvyra (fentanyl), indicated for controlling postoperative pain associated with surgical procedures in dogs. The applicable regulatory review period for Recuvyra is 2,092 days, which includes 2,037 days during
FDA Policy/General
Federal Register notice: FDA has announced the availability of a draft guidance on “Identifying Trading Partners Under the Drug Supply Chain Security Act.” The document provides recommendations on how to categorize entities in the drug supply chain in accordance with this law. It also explains how to determine when certain
FDA Policy/General
FDA Withdraws NDA Approval of Bayer’s Baycol Federal Register notice: FDA announces that at the company’s request it is withdrawing the approval of a Bayer NDA for Baycol (cerivastatin sodium) tablets. 08/17/2017 Wyeth’s Cordarone Not Withdrawn Due to Safety/Effectiveness Federal Register notice: FDA determines
FDA Policy/General
Alvogen has signed a definitive agreement to acquire Omega Bittner, a Russia-based pharmaceutical firm owned by Perrigo. Omega Bittner markets over-the-counter products in Russia, including Lactacyd, Aflubin and Paranit. Alvogen says the acquisition supports its strategy to gain more exposure to Russia’s high growth market. It
FDA Policy/General
Federal Register notice: FDA announces that at the company’s request it is withdrawing the approval of a Bayer NDA for Baycol (cerivastatin sodium) tablets, 0.05 milligrams (mg), 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, and 0.8 mg. The drug was approved in