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EU, U.S. and Japanese regulators join forces on antibiotic trials
June 13, 2017
Ben Adams, FierceBiotech
The three drug regulators from Europe, the U.S. and Japan have come together in a data share program aimed at boosting antibiotic development. Long held as one of the most overlooked but potentially devastating areas of development, antibiotic resistance and a lack of new meds in this area have increasingly become a major concern for governments.

House Committee Considers Four Device Bills to Add to User Fee Reauthorization
May 2, 2017
Zachary Brennan, Regulatory Affairs Professionals Society
The House Energy & Commerce Committee on Tuesday discussed four bipartisan bills likely to be added to the user fee reauthorization package that aim to improve the US Food and Drug Administration’s (FDA) regulation of medical devices and inspections of device manufacturing sites. 

FDA hits the ground running with 12 first-quarter 2017 drug approvals
April 18, 2017
Eric Sangonowsky, Fierce Pharma
After a big slowdown in 2016, FDA new drug approvals got off to a hot start in 2017. During the first quarter, the regulator signed off on more new meds than during the same period of any year in recent history.

Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union
FDA News Release
March 2, 2017
The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.

FDA Issues Final Guidance on Postmarket Cybersecurity
January 10, 2017
The National Law Review
FDA has encouraged device manufacturers to address cybersecurity throughout the product lifecycle, including during the design, development, production, distribution, deployment, and maintenance of the device. The Final Guidance, however, focuses on postmarket management of such risks. In particular, it advises manufacturers on the applicability of FDA’s medical device correction and removal reporting requirements (21 C.F.R. Part 806) to actions taken to address cybersecurity vulnerabilities.

FDA Offers Final Guidance on CGMP Requirements for Combo Products
January 10, 2017
Zachary Brennan, Regulatory Affairs Professionals Society
The US Food and Drug Administration (FDA) on Tuesday released final guidance describing and explaining the current good manufacturing practice (CGMP) requirements for combination products, first released in January 2013.The guidance addresses general considerations for CGMP requirements for these drug-drug, drug-device, drug-biologic or biologic-device combination products and the purpose and content of specific provisions from 21 CFR part 4.

The Top Three International Regulatory Compliance Challenges
January 9, 2017
The challenge of complying with supply chain regulations is now greater than ever. Legislators around the world have responded to the risks posed to healthcare supply chains with new requirements. The upshot is that healthcare manufacturers and distributors must contend with a global patchwork of more stringent rules. These legislative efforts are now starting to take effect. In this paper, we look at three pieces of supply chain legislation and how they are affecting compliance.

FDA Final Rule Focuses on Quicker Generic Approvals
Tuesday, November 15, 2016
Jennifer Barrett
The FDA is issuing a final rule on generic drug applications, hoping to quicken the generic approvals process. On October 6, 2016, the FDA published the rule in the Federal Register as a finalization to the proposed rule issued on February 6, 2015.

FDA Releases Q7 GMP for API Guidance
Monday, October 3, 2016
On Sept. 29, 2016, FDA published the revised Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry. The guidance document address good manufacturing practices (GMPs) for a quality management system for APIs. The guidance also helps companies ensure the purported API quality and purity characteristics are met. The guidance replaces Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients and changes the International Council for Harmonization (ICH) codification from Q7A to Q7.

FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies

Tuesday, August 23, 2016
Zachary Brennan, Regulatory Affairs Professionals Society
The US Food and Drug Administration (FDA) on Tuesday proposed to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach for these safety and toxicity studies. 

Data Integrity: New Draft Guidance and Q&A
Thursday, August 11, 2016
Zachary Brennan, Regulatory Affairs Professionals Society
The European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on Thursday released new draft guidance and a question and answer document to help ensure that data integrity is maintained during the process of testing, manufacturing, packaging, distributing and monitoring medicines. 

​FDA Comes Through on Promise to Release NGS Device Draft Guidelines Expeditiously
Tuesday, July 12, 2016
The National Law Review
Building on last year’s public workshops related to Next-Generation Sequencing (NGS) and expanding its efforts to advance the Obama Administration’s Precision Medicine Initiative, the FDA late last week released two draft guidance documents on different aspects of NGS-based diagnostic tests.

FDA to Drug Compounders: Inspection Changes Coming in August

Tuesday, July 12, 2016
Zachary Brennan, Regulatory Affairs Professionals Society
The US Food and Drug Administration (FDA) on Tuesday announced major changes with respect to inspections of drug compounders as infections linked to poor quality drugs continue to crop up.

Brexit means EMA must find a new home, and so much more
June 24, 2016
Eric Palmer, FiercePharma
The European Medicines Agency, the drug regulator for Europe, is headquartered in London. The problem is that the U.K. voted Thursday to leave the European Union, meaning the EMA will now have to leave and find a new home. It is one of the countless concerns that affect the pharma industry with Britain’s historic vote to give up on European unity. 

FDA Issues Draft Guidance on Critical Quality Attributes for Chewable Tablets
June 16, 2016
Michael Mezher, Regulatory Affairs Professionals Society
The US Food and Drug Administration (FDA) on Thursday issued new draft guidance covering the quality attributes drugmakers should consider when developing chewable tablets. 

Taiwanese API maker abandons U.S. market rather than concede to FDA
June 8, 2016
Eric Palmer, Fierce Pharma
Most drugmakers readily agree to invest in plant upgrades if the FDA cites them for violations so they can keep selling products into the U.S., the world's largest pharma market. But not KO DA Pharmaceutical. When FDA inspectors found issues during a recent inspection, the Taiwanese API maker decided to quit shipping products to the U.S. rather than change its production.  

FDA Rejects Highest Number of Monthly Generic Drug Applications Ever
June 8, 2016
Zachary Brennan, Regulatory Affairs Professional Society
The common refrain that the US Food and Drug Administration (FDA) has been approving an exorbitantly high number of drug applications for generic drugs, known as abbreviated new drug applications (ANDAs), to increase market competition in recent years is slowing down in recent months.

FDA Calls on Companies to Select 10 Suffixes for Biosimilar, Biologic Names
Wednesday, June 1, 2016
Zachary Brennan, Regulatory Affairs Professionals Society
The US Food and Drug Administration (FDA) on Wednesday announced a new tweak to its guidance on the non-proprietary names for biosimilars and will allow companies to propose 10 suffixes for each new biosimilar and biologic, as opposed to the previous proposal of having each company select one random suffix. 

Legislative Overseers Continue To Criticize FDA On Regulation-By-Guidance
Tuesday, May 31, 2016
Glenn G. Lammi, Contributor
Four members of the Senate Health, Education, Labor, and Pensions Committee (HELP), including Chairman Lamar Alexander, wrote Food & Drug Administration (FDA) Commissioner Robert Califf earlier this month to reiterate their concerns with FDA’s use of guidance as regulatory tool. 

F.D.A. Delays Rule on Generic Drug Labels
Thursday, May 19, 2016
New York Times
The Food and Drug Administration has decided to put off until 2017 a decision about whether to require generic drug makers to take more responsibility for warning patients about the risks of their products

FDA Issues Draft Guidance Encouraging More Widespread Use of Electronic Health Record Data in Clinical Trials
Tuesday, May 17, 2016 The National Law Review
On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations (“Draft Guidance”).