Drugs
Washington Legal Foundation (WLF) says that FDA should ease its restrictions on manufacturer dissemination of truthful and non-misleading information about off-label uses of approved medical products. In 12/30/16 comments provided in response to an agency 9/1/16 formal request for input, WLF said that the
Drugs
FDA issued 14 complete response (CR) letters in 2016, the highest number since 2009, which contributed to the disappointing 22 new molecular entity approvals (see earlier story) last year, according to a final update by retiring CDER Office of New Drugs director John Jenkins. “Each application for a new drug
Drugs
FDA has issued Innocoll a refuse-to-file letter for Xaracoll, the company’s combination product candidate for treating postsurgical pain, because the submission was not sufficiently complete to permit a substantive review. In the letter, FDA indicated, among other things, that Xaracoll should be characterized as a drug/device
Drugs
FDA has posted a guidance on “Medical Device Accessories – Describing Accessories and Classification Pathway for New Accessory Types.”The document is intended to describe FDA’s policy concerning the classification of accessories and discuss the application of that policy to devices that are commonly used as accessories to other medical
Drugs
FDA has denied a 9/22/14 petition submitted by attorney, pharmacist, and former FDAer Larry Pilot asking that it switch oral contraceptive products from prescription-only to over-the-counter purchasing status. The petition said that such a switch was appropriate in light of “user awareness … coupled with product
Drugs
FDA has denied a Par Sterile Products petition asking that it not approve any ANDA for an epinephrine injection 1 mg/mL product in a 1 mL vial, ampule, pre-filled syringe, or similar parenteral administration modality that does not contain the same inactive ingredients in the same amounts as
Drugs
FDA has released a guidance on “ANDA Submissions – Refuse-to-Receive Standards” that is intended to assist applicants preparing to submit ANDAs and prior approval supplements for which the applicant is seeking approval of a new strength of the drug product. The document highlights deficiencies that may cause the agency
Drugs
FDA has issued a guidance on “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.” The document describes the general framework for medical device decision making in the product availability, compliance, and enforcement arenas. “Product availability and other medical device compliance and enforcement decisions
Drugs
CDER director Janet Woodcock says that FDA is considering whether to add immediate-release opioids to the REMS program that is in place for extended-release/long-acting opioids. Speaking in a Director’s Podcast, Woodcock also says the agency will be expanding its view on things that a practitioner
FDA Policy/General
An FDA annual report summarizing sales and distribution data for all antimicrobial drugs approved for use in food-producing animals shows that sales and distribution of all antimicrobials increased 1% from 2014 through 2015, tied for the lowest annual increase since 2009. The report says that the percentage of the
Drugs
Attorney Al Cacozza (Ropes & Gray) says in a year-end podcast on coming changes to FDA that President-elect Donald Trump is a “big wild card” in the public policy debate over drug pricing. “On the campaign trail,” Cacozza says, “he railed against high drug prices, and vowed to
Drugs
FDA has given accelerated approval to Clovis Oncology’s Rubraca (rucaparib) to treat women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation, deleterious BRCA, as identified by an FDA-approved companion diagnostic test. An agency news release
Drugs
Eighteen Democratic and Independent senators led by Sens. Sherrod Brown (D-OH) and Al Franken (D-MN) have written to president-elect Donald Trump asking him to work with Congress to lower drug prices and suggesting five steps that could be taken. The letter reminds Trump of his campaign promise
Drugs
FDA has approved Biogen’s Spinraza (nusinersen) for treating children and adults with spinal muscular atrophy (SMA). Spinraza, the first drug indicated for this condition, is an injection administered into the fluid surrounding the spinal cord, FDA said in an announcement. The agency said it worked closely with Biogen and
Drugs
FDA has published a guidance, “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product,” to provide information about the overarching concepts related to clinical pharmacology studies for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing
Drugs
FDA Webview has posted Warning Letter summaries for letters released during our holiday break (12/19 to 12/30). They can be accessed by clicking on the link following each letter. Antibioticos do Brasil Sao Paulo,Brazil (12/8): FDA inspected the firm’s manufacturing facility last April and cited
Drugs
A 12/7-12/15/15 FDA inspection at Wockhardt Limited, Mumbai, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients, according to a 12/23/16 Warning Letter. The letter says that violations and deviations
Drugs
FDA has published a draft guidance, Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information, discussing the requirements and implementation of the Federal Food, Drug, and Cosmetic Act about valid electronic submissions of manufacturing establishment information (MEI). The document says that 24 months after the draft has been
Drugs
CDER saw a dramatic drop in innovative new drug approvals in 2016 — just 22 approved (see listing here) which is half as many as were approved in 2015. In his last annual review of the Center’s approval performance presentation before retiring, Office of New Drugs director John Jenkins said
Drugs
Agios Pharmaceuticals has pulled the plug on its development program involving its second pyruvate kinase-R activator, AG-519, and withdrew its investigational new drug application 12/15 following a verbal notification of an FDA clinical hold. “These decisions do not affect the company’s ongoing global Phase 2 study
Drugs
FDA has approved updates to Pfizer’s Chantix (varenicline) labeling, including removal of a boxed warning on serious neuropsychiatric events. The removal was based on data from the EAGLES study, the largest smoking cessation clinical trial in patients without and with a history of psychiatric disorder. Additional labeling revisions based
Drugs
The Department of Justice (DoJ) says it obtained more than $4.7 billion in settlements and judgments from civil cases involving fraud and false claims against the government in FY 2016, including $2.5 billion from the healthcare industry (drug companies, medical device companies, hospitals, nursing homes, laboratories, and doctors)